Regulatory convergence and cooperation among the authorities in the field of medical products (medicines and medical devices) are essential to deliver safe and efficacious products quickly to patients. APEC established the Regulatory Harmonization Steering Committee (RHSC) to advance this cause among member economies. This paper identifies four areas of appropriate regulatory practice in which APEC economies could converge, and explores the feasible processes of how APEC economies could cooperate in order to bring about realization of a maximum level of regulatory convergence by 2020. Keywords: APEC, Regulatory convergence and cooperation, Key performance indicators Background health and economic development among its 21 econ- Since the inception of the International Council for Har- omies (APEC Member Economies 2017). Convergence monisation of Technical Requirements for Pharmaceuti- will focus on the process of aligning multiple countries’ cals for Human Use (ICH) in 1990, harmonization of regulations for greater regulatory cooperation and does regulatory requirements has been progressively and suc- not necessarily require the regulations to be “harmo- cessfully achieved in major jurisdictions around the nized”. According to an RHSC strategic framework world. This has benefited global public health and na- document released in 2010, while each economy may tional health systems mainly through transparency and adopt each phase on its own timeframe, the ultimate predictability of what scientific dataset is required to aim would be for APEC economies to achieve the max- support the approval of a new pharmaceutical, hence ad- imum level of regulatory convergence feasible by 2020 vancing the innovation of drug development. In addition, (APEC RHSC Vision 2020). convergence and cooperation (information exchange, This paper identified four areas of appropriate regula- work sharing, reliance, and recognition) (WHO Good tory practice in which APEC economies could converge. Regulatory Practices 2016) have been facilitated among The four areas are related to the use of (1) Certificate of the ICH regulatory members (ICH Official website 2018) Pharmaceutical Product (CPP); (2) the Pharmaceutical in order to optimize efficiency in regulatory processes Inspection Co-operation Scheme (PIC/S) membership; without duplication in efforts. (3) managing multiple sites in one license; and (4) In 2010, the RHSC established under APEC’s Life Sci- risk-based reliance evaluation system. These four areas ences Innovation Forum (LSIF) advocated for regulatory could be explored together with the feasible processes of convergence in pharmaceuticals for improved public how APEC economies could cooperate that would facili- tate the defining or development of key performance in- dicators (KPIs) to measure the progress of convergence * Correspondence: email@example.com to assess whether “the regulatory requirements across Asia Pacific Technical Regulatory Policy, Pharma Technical Regulatory Policy and International Operations, Roche Singapore Technical Operations, F. economies become more similar or ‘aligned’ over time” Hoffmann La-Roche Ltd, Singapore, Singapore (APEC RHSC Vision 2020). Full list of author information is available at the end of the article © The Author(s). 2018 Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. Chong et al. AAPS Open (2018) 4:4 Page 2 of 8 Evolution of regulatory harmonization, Level 1 cooperation is feasible for regulators who convergence, and cooperation: The ICH adopt ICH requirements but are not yet full members of experience ICH, and who can leverage on the assessments com- From the early 1990s onwards, international regulatory pleted by stringent regulatory authorities (SRA) (WHO harmonization for new drug development has been pur- collaborative procedure 2017). The use of a SRA’s assess- sued under the efforts of ICH. This has given rise to a ment report enables a non-ICH regulator to expedite standardized format, i.e. the common technical docu- learning of ICH guidelines applied to evaluate scientific ment (CTD), for companies to consolidate their scien- datasets and arriving at sound decisions while minimiz- tific dataset for regulators’ evaluation. Over the years, ing duplication efforts. ICH members have also jointly developed some 70 Level 2 cooperation takes place when the regulatory guidelines to provide scientific principles and assessment practice made on the data is also harmonized. For ex- details of the various sections listed in the CTD. ample, when confidence building is in place and the pro- Through the acceptance and full implementation of ICH cedures for Good Manufacturing Practice (GMP) audit guidelines by ICH members, regulatory requirements are harmonized, one authority can rely on the audit re- were harmonized among the ICH members. This great ports of another authority to base its decisions without achievement has not only advanced access of new drugs duplicating the physical auditing process of the same to patients, but has also become the gold standard by manufacturing premises. This mutual reliance on work which any regulatory authority can base its assessment products of other authorities or work sharing among au- framework for approving a new drug that is shown to be thorities is the next level of regulatory cooperation. safe, efficacious and of good quality. Level 3 and the highest level of regulatory cooperation The ICH efforts have created a “common language” is mutual recognition. However, the sharing of regula- among international regulatory stakeholders and has tory decisions among national regulatory authorities promoted increasing cooperation among national regula- cannot be achieved easily due to factors such as differ- tory authorities. Three levels of cooperation can gener- ences in expertise and capacity, legal and risk frame- ally be identified as shown in the shaded ellipses of works, mutual understanding of systems and processes, Fig. 1 (Tominaga 2013): and sovereignty issues. It is even more difficult when the Level 1: Information sharing/reliance. process needs formalization and a legal arrangement Level 2: Working-sharing/mutual reliance. such as a mutual recognition arrangement (MRA) must Level 3: Mutual recognition. be concluded. Fig. 1 (Tominaga 2013) Level of harmonization and regulatory cooperation. As the degree of regulatory cooperation advances from sharing of submitted data to work sharing/mutual reliance on other authorities’ work, and to decision sharing/mutual reliance on other authorities’ decision, the necessary level of harmonization also advances from that of technical requirements to regulatory practice and to decision criteria. Also necessary are other efforts such as confidence building and legal arrangements among the participating regulatory authorities Chong et al. AAPS Open (2018) 4:4 Page 3 of 8 The PIC/S established since 1995, is an extension to organizations, with ICH as the primary source. The ef- the Pharmaceutical Inspection Convention (PIC) of forts of RHSC focus on “convergence”, i.e. on the 1970. PIC/S is a non-binding co-operative agreement be- process of aligning APEC economies’ regulatory require- tween regulatory authorities in the field of GMP of me- ments based on best practices for optimal regulatory dicinal products for human or veterinary use. PIC/S cooperation. aims at harmonizing the inspection procedures world- For the purposes of APEC RHSC activities and this wide by developing common GMP standard and provide Framework, the concept of “harmonization” represents training opportunities to inspectors. It also aims to facili- the development and adoption of the same standards or tate co-operation and networking between regulatory requirements. Harmonization may also be applied to authorities (PIC/S Brochure 2016). The common stan- procedures and practices to see that these are the same dards and practices of ICH and PIC/S requirements have across economies. The significance of the introduction facilitated the following examples of cooperation among of this concept is the emphasis that harmonization and ICH members: convergence of drug regulations among multiple coun- tries across the Asia-Pacific are ultimately for regulatory (a) Information-sharing/reliance: Health Canada cooperation to expedite the access of patients to medi- does not evaluate the drug master file of a generic cines and to benefit public health. In order for cooper- drug if a Certificate of Suitability (CEP) issued by ation at the various levels (Fig. 1) to take place, the European Directorate for the Quality of regulatory processes and practices essential for such co- Medicines and Healthcare (EDQM) is already operation will first need to be put in place. However, available (Government of Canada 2017); while harmonization refers to processes that develop (b) Work-sharing/mutual reliance: The U.S. Food uniform standards across jurisdictions, regulatory con- and Drug Administration (USFDA) and European vergence is a more pragmatic and feasible approach that Medicines Agency (EMA) initiated their pilot joint better accommodates sovereignty and legal issues which assessment of Quality by Design dossier (EMA-FDA make it difficult to achieve complete standardization pilot program 2013); across different economies. (c) Mutual recognition: US FDA and EMA are This section aims to recommend four prioritized areas currently developing a GMP MRA (EU-US mutual of appropriate regulatory practice in which convergence recognition of inspections 2017). can be maximally achieved by 2020. Accordingly, KPIs can be developed in relation to these four areas to meas- Best practices and feasible processes for APEC ure the progress of convergence to determine whether economies’ convergence the regulatory requirements across economies become In 2010, the APEC RHSC advocated for regulatory con- more aligned over time. The four areas are: vergence in pharmaceuticals among its 21 economies so as to improve public health and economic development. A. The appropriate use of the CPP; The term “convergence” was clearly defined by the B. The appropriate use of PIC/S membership; RHSC (APEC RHSC Vision 2020) with the understand- C. The appropriate management of multiple sites; and ing that: D. The appropriate use of risk-based evaluation based on information Regulatory convergence represents a voluntary process whereby the regulatory requirements across (A) The appropriate use of the CPP economies become more similar or “aligned” over The CPP was developed by the WHO as a tool to sup- time as a result of the gradual adoption of port product registration among national regulatory au- internationally recognized technical guidance thorities, especially in developing countries (WHO documents, standards and scientific principles Certification Scheme 2016). It serves as evidence that a (harmonization) and common or similar practices product has been approved by the national regulatory and procedures. authority that issued the CPP. The intent of the CPP is It does not represent the harmonization of laws and therefore to be used in lieu of full or partial review by regulations, which is not necessary to allow for the the recipient country. As the original regulatory mem- alignment of technical requirements and for greater bers of ICH conduct their reviews independently, they regulatory cooperation. do not rely on the CPP approach for their decision-making. On the other hand, most of the APEC The RHSC initiative does not seek to develop new economies had adopted the use of CPP in their regula- guidances; rather, it relies upon existing guidances tory systems for product approval. Previously, Singapore already developed by international harmonization (a member of both APEC and ICH) used to request for Chong et al. AAPS Open (2018) 4:4 Page 4 of 8 CPPs but as its regulatory system matured, the require- of inspections. It is recommended that these PIC/S ment for the CPP has been removed from both its pre- members streamline existing procedures so that: and post-marketing control requirements. With “convergence”, the understanding is that “each (a) The current GMP related documentation required economy may adopt each phase on its own timeframe” before inspections to support compliance (APEC RHSC Vision 2020). In discussing a phased ap- assessment are minimized with country specific proach to achieve a maximum level of regulatory con- requirements such as unnecessary declaration vergence by 2020, the 21 APEC economies may be forms, various reports and raw data, etc. broadly placed into 2 groups, namely those that depend (Nishimura 2017) on a CPP for regulatory decision making and those that (b) Acceptance/reliance of PIC/S member inspection do not. reports or GMP certification is in place so that Australia, Canada, Japan, Singapore and the United inspection efforts are not unnecessarily duplicated States of America (USA) are examples of non (WHO Guidance on Good Practices 2017). Instead, CPP-dependent APEC economies which do not require on-site inspections should focus on manufacturing CPP for their product registrations. It is worth noting sites which are of concern, which have not historic- that these five examples are both regulatory members of ally been inspected by PIC/S inspectors, or have re- PIC/S and ICH. Another observation is that various cently been noted to have GMP/quality concerns. forms of cooperation already exist among these five APEC economies as that described in the preceding sec- (C) The appropriate management of multiple sites tion. Such cooperation is facilitated by the common In October 2015, Chinese Taipei formally issued a new standards of ICH coupled with regulatory systems regulatory policy to allow a single product made in mul- aligned with international practices implemented in their tiple sites to only have one license (Taiwan regulation regulatory processes. 2015). Furthermore, when a new site is required to be Among the APEC economies which are considered added after its initial approval, a new license will not be “CPP-dependent”, China in recent years has undergone warranted. Chinese Taipei changed its policy to align a series of regulatory reforms by converging its require- with international standards of regulating multi-sites in ments towards international standards. One of the revi- one license, and managing subsequent site additions as a sions China made in October 2017 is working towards post approval change, similar to what is practiced by the removal of CPP for Clinical Trial Application (CTA) ICH members. and New Drug Application (NDA) applications for new The one-site-one-license process is commonly de- chemical products and innovative biological products ployed among the APEC economies which are “CPP-de- (CFDA Order No. 35 2017). It would therefore be useful pendent” (ASEAN Variation Guidelines 2013; Hong for China to share with the other CPP-dependent APEC Kong Drug Office 2017), and this approach is quite the economies its rationale and approach for progressing opposite of that practiced by ICH members. This results from CPP-dependent to independent regulatory reviews in highly duplicative and onerous procedures which are based on ICH standards. mainly administrative and have little (if no) positive im- As the CPP is used to replace full or partial review of pact on quality, safety and efficacy. The burden to apply quality, safety and efficacy in line with WHO’s advice, it and maintain multiple licenses for a single product is recommended that the need for CPP dependency significantly reduces product sourcing flexibility and amongst APEC economies that have already acquired affects continuity of supply, thus impacting patients in PIC/S membership be reviewed, since these countries the case of product shortages. It is therefore strongly have already demonstrated capability to comply with recommended that the APEC economies with the international standards. It is therefore timely to review one-site-one-license requirement consider reviewing this the relevance of CPP in both their pre- and system to allow for single licenses for multiple sites in post-marketing systems (WHO CPP Scheme 2015). order to converge regional regulatory practice in this However, for economies yet to achieve PIC/S member- particular area. ship, the CPP remains relevant in line with WHO advice. (D) The appropriate use of risk-based evaluation based on information-sharing (B) The appropriate use of PIC/S membership In today’s regulatory landscape, public expectation is The APEC economies that are PIC/S members could growing for maturing regulatory authorities to improve utilize the PIC/S network and common high standards performance and facilitate timely access to safe, effective to make significant positive moves towards greater con- and quality products. This becomes more challenging as vergence in GMP compliance assessment and conduct increasingly complex technologies and advanced Chong et al. AAPS Open (2018) 4:4 Page 5 of 8 therapies emerge. It is extremely important for regula- documents needed to be provided by the industry and tory authorities to prioritize optimal use of resources, which departments in the agency should evaluate the doc- while working towards attaining fully functional and ef- uments throughout the life cycle of the products. Pre- and fective regulatory systems according to international post-marketing experts were organized into one common standards such as PIC/S. While working towards attain- vigilance team to take charge of alert responses through- ing PIC/S membership and to manage issues of scarce out the entire life-cycle of products, with activities includ- resources and expertise, APEC economies could con- ing quality surveillance testing and pharmacovigilance sider adopting more risk-based approaches that leverage monitoring. This streamlined the regulatory procedures to on evaluations conducted by stringent regulatory author- enable a seamless, integrated and science-based frame- ities, and focusing their regulatory resources on issues work that is highly effective in risk mitigation, and also that are of locally critical significance. This will not only less bureaucratic in nature. To further increase efficiencies promote greater convergence in areas where appropriate and avoid duplicative work, HSA introduced the “verifica- scientific and technical assessments have already been tion route” in 2004; this requires product approval by two completed by allied regulatory authorities but also help or more reference agencies and HSA focuses on verifying deploy expertise more efficiently (WHO Good Regula- the benefit-risk based on the assessment report of the se- tory Practices 2016). An overview of Singapore’s ap- lected reference agencies. This route has a short timeline proach to risk-based evaluation that adopted this of 60 working days (Patel et al. 2017). pragmatic approach to optimize limited resources effect- On the basis of similarity in standard and procedures, ively while maintaining robustness in its decisions con- a MRA on GMP conformity assessment between stitutes a useful case study. Australia and Singapore was signed on 26 February The Singapore Health Sciences Authority (HSA) 2001. The agreement is of treaty status and includes the attained PIC/S membership in 2000 (PIC/S members). sector on Medicinal Product GMP Inspection. Under This enabled HSA to be a member of a forum of estab- the MRA, the Therapeutic Goods Administration (TGA) lished inspectors for networking and confidence build- of Australia accepts the conclusions of inspections of ing. For product evaluation, HSA leveraged on public manufacturers carried out by GMP Auditors of HSA, assessment reports and stringent regulations of its five Singapore and vice-versa. The GMP inspection report/ Reference Agencies (HSA Guidance (page 42 of 166) certificate is made available to the requesting party ex- 2016) to approve products. Through the years of cooper- peditiously, and the time taken should not exceed 30 cal- ation with these five agencies (involving memorandums endar days (HSA International Accreditation 2001). In of understanding, communication, training, information 2011, two of Singapore’s Reference Agencies, Health sharing, and staff attachments), HSA identified elements Canada and the TGA, invited Singapore to embark on a in the benefit-risk assessment that are more critical in work sharing initiative for generics evaluation (Inter- the local context, and HSA was able to leverage the national Consortium 2012). This highlights that work of larger agencies while ensuring the benefit-risk Singapore is recognized as a credible partner in a assessments were applicable to the Singapore population four-member regulatory consortium that was established (Patel et al. 2017). At the same time, the agency also im- in 2007 (Australia-Canada-Singapore-Switzerland 2017). plemented process reviews whereby its requirements be- This brief case study illustrates how the Singapore au- come more aligned over time to established regulatory thority successfully achieved regulatory convergence by authorities as a result of the gradual adoption of inter- introducing sound risk-based approaches in its regula- nationally recognized guidance documents, scientific tory system through cooperation with selected inter- principles and best practices. It is of note that HSA national partners that it established Memorandums of eventually attained full membership of ICH in 2017 Understanding (MOUs) and confidentiality agreements (HSA gains international acceptance 2017). This enabled with. This provides important lessons on how relatively Singapore to develop the necessary capabilities to per- resource-strapped regulatory agencies can first leverage form full reviews for first-in-the-world products that had on stringent authorities’ work results and later become not been registered elsewhere (Wong & Lim 2003). Cap- aligned to the international standards and best practices abilities to perform independent evaluation remain stra- that enable meaningful cooperation with stringent au- tegically critical and this ensures support for regional thorities to take place. The Singapore experience biomedical research and development growth population (Deloitte & Touche LLP 2017; Lim 2016) can serve as a (Patel et al. 2017). feasible model for other APEC economies as they de- To ensure the effective use of resources, HSA also velop strategies and procedures that leverage on assess- conducted a series of business process reviews ments conducted by stringent regulatory authorities, in (Haydock I 2010) to optimize productivity while ensur- line with WHO’s recommendation (WHO Good Regula- ing robustness. This enabled HSA to rationalize what tory Practices 2016; WHO collaborative procedure 2017). Chong et al. AAPS Open (2018) 4:4 Page 6 of 8 Proposed KPIs to measure APEC regulatory (c) APEC economies with membership of both PIC/S convergence and cooperation and ICH: Based on the discussion above, several KPIs linked to the four areas of appropriate regulatory practice could (i) Number of economies with work-sharing arrange- be used to help measure the progress of regulatory con- ments and mechanisms; vergence on regulatory approval procedures for medical (ii) Number of economies with reliance/mutual products across APEC economies by 2020 (Fig. 2). recognition arrangements and mechanisms. The potential KPIs for the various economy groupings are as follows: Regulatory convergence and cooperation should be promoted together. This is because for convergence to (a) APEC economies not yet a member of PIC/S: be meaningful, greater targeted cooperation amongst regulatory authorities should be realized in areas such as (i) Number of economies with risk-based reliance information sharing, relying on each other’s decisions evaluation system; and work sharing to minimize duplication and enhance (ii) Number of economies attaining PIC/S status. efficiency. Accordingly, the degree of success of regula- tory convergence and cooperation will need to be mea- (b) APEC economies not yet a member of ICH: sured by defining or developing a combination of KPIs that collectively measure convergence and cooperation. (i) Number of economies removing CPP dependence and aligning with ICH practice; Capacity building (ii) Number of economies aligning GMP To help promote convergence across the APEC region, documentation and non-duplicative inspection to capacity building is a clear need and enabler. Capacity that of international practice; building activities for regulatory authorities should be (iii)Number of economies managing multi-sites in a designed with clear awareness that one major purpose is single license. for trainees to acquire skills and knowledge to enable Fig. 2 Progress of convergence measurable by proposed KPIs before 2018 to 2020 and beyond Chong et al. AAPS Open (2018) 4:4 Page 7 of 8 their organizations to start leveraging on stringent au- their populations are safe, efficacious and of good qual- thorities’ assessments and decisions in an appropriate ity. It is also the duty of these authorities to expedite ac- manner, while developing their own regulatory capabil- cess of patients to the medicines and medical devices ities to conduct independent, science-based reviews and they need in a timely manner. With the ever increasing other important local regulatory functions such as phar- complexity of new biomedical and biotechnological macovigilance and supply chain integrity, in line with products and development, coupled with the challenges WHO’s recommendation that regulatory authorities arising from the global supply chain, the need for regula- should focus “on what cannot be done by others while tory convergence and cooperation is essential rather leveraging the work of other trusted NRAs and regula- than optional. In today’s world, no single regulatory au- tory networks” (WHO Good Regulatory Practices 2016). thority can claim that it is fully resourced to manage all APEC has already introduced the frameworks for iden- issues relating to pre- and post-marketing of all the tifying and supporting Centres of Excellence (COEs) medicines and medical devices available in its country. such as those in Duke-NUS Medical School in The rational way forward is therefore to optimize the Singapore, Beijing University, Japan’s Asia Training Cen- use of scarce resources in cooperation with regional and ter and Northwestern University in the USA (APEC international regulatory counterparts, while administer- Harmonization Center 2018). The courses of these ing a robust regulatory system that does not duplicate COEs should aim to incorporate training on the use of efforts to ensure timely access of health products to pa- public assessment reports or inspection reports issued tients in a reliable and efficient manner. by the stringent authorities to identify elements that APEC’s continuing efforts to develop and promulgate matter in order to conduct appropriate benefit-risk as- good review practices are paving the way toward the sessments and reach sound regulatory decisions without sharing of review reports among participating authorities compromising on scientific robustness. Trainees should (Lin et al. 2015). Specifically, APEC regulators should be encouraged to develop risk-based reliance evaluation embark on aligning best practices and processes of those processes in their respective regulatory frameworks and prioritized areas as highlighted in this paper, as essential become competent to eventually conduct independent building blocks for ensuring the success of regulatory evaluations based on international standards. convergence. APEC economies can draw lessons from each other’s Abbreviations experiences to expedite convergence through meaningful APEC: Asia Pacific Economic Cooperation; CEP: Certificate of suitability; practical training that will bring about maximal out- COE: Centres of excellence; CPP: Certificate of pharmaceutical product; comes. Based on the success stories of various APEC CTA: Clinical trial application; CTD: Common technical document; EDQM: European directorate for the quality of medicines and healthcare; economies achieving convergence efforts cited in this EMA: European Medicines Agency; GMP: Good manufacturing practice; paper, the following economies could potentially be in- HSA: Health Sciences Authority; ICH: International council for harmonisation vited to share experience in the context of existing or of technical requirements for pharmaceuticals for human use; LSIF: Life sciences innovation forum; MOU: Memorandums of understanding; new CoEs: MRA: Mutual recognition arrangement; NDA: New drug application; PIC: Pharmaceutical inspection convention; PIC/S: The pharmaceutical (a) China - streamlining CPP dependency; inspection co-operation scheme; RHSC: Regulatory Harmonization Steering Committee; SRA: Stringent Regulatory Authorities; TGA: Therapeutic Goods (b) Australia and Singapore - risk-based evaluation Administration; USA: United States of America; USFDA: U.S. Food and Drug procedures based on information-sharing; Administration (c) Mexico - attaining PIC/S membership (Mexico to join PIC/S 2017); Acknowledgements (d) Canada, Australia and Singapore - minimizing SSFC thanks Dr. Wassim Nashabeh from F. Hoffmann La-Roche Ltd. for his in- spirational leadership in the advocacy of APEC regulatory convergence. The country specific GMP documentation required as authors acknowledge Dr. Dorothy Toh from Singapore HSA for reviewing the pre-inspection packages and non-duplicative case study of her organization, and Ms. Shamsuria Sumsoory for providing inspection based on best practices (HSA Guidance editorial support. Page 51–55, 2016); (e) South Korea - becoming ICH member by the Funding Processing fee of AAPS open was provided by SSFC’s organization. adoption of ICH Q1, Q7 and E6 guidelines (ICH Members & Observers 2017); Authors’ contributions (f) Chinese Taipei - managing multi-sites in one TT contributed to the writing on ICH and the creation of Fig. 1 with its level license. of convergence and cooperation. SSFC formulated the methodology with the four ideas of best practices identified, as well as the proposed KPIs to measure regulatory convergence. JCWL created the recommendation to Conclusion incorporate sharing of the APEC economies’ success into the existing CoEs National regulatory authorities are charged with the re- as potential model for enhancing capacity building. Each author reviewed sponsibility to ensure that the health products used by and approved the final version of the paper. Chong et al. AAPS Open (2018) 4:4 Page 8 of 8 Competing interests Importation_Distribution/Overview/International_Accreditation_Liaisons_ The authors declares that they have no competing interests. and_Agreements.html ICH Members & Observers (2017) http://www.ich.org/about/members-observers.html ICH Official website (2018) http://www.ich.org/home.html Publisher’sNote International Consortium Aims to Facilitate Availability of Generic Drugs for Springer Nature remains neutral with regard to jurisdictional claims in Patients Through Focus on Generic Drug Review Collaboration (2012). http:// published maps and institutional affiliations. www.hsa.gov.sg/content/hsa/en/News_Events/HSA_Updates/2012/ international_consortium.html Author details Lim J-CW (co-author). Healthcare Regulation. In: Singapore’s Health Care System Asia Pacific Technical Regulatory Policy, Pharma Technical Regulatory Policy – What 50 Years Have Achieved. World Scientific Publishing Co Pte Ltd; 2016. and International Operations, Roche Singapore Technical Operations, F. p94–116. ISBN 9814696048 Hoffmann La-Roche Ltd, Singapore, Singapore. Centre of Regulatory Lin H-Y, Chen S J-Y, Gau C-S, Liu L-L (2015) APEC Workshop Report of Good Excellence, Duke-NUS Medical School, Singapore, Singapore. Review Practices on Medical Products, DIA Therapeutic Innovation & Pharmaceuticals and Medical Devices Agency (PMDA), Tokyo, Japan. Regulatory Science 49(4):483–492. DOI: https://doi.org/10.1177/ 2168479015572835. http://journals.sagepub.com/doi/pdf/10.1177/ Received: 22 January 2018 Accepted: 23 April 2018 st Mexico to join PIC/S from January 1 2018 (2017) https://www.picscheme.org/ en/news?itemid=44 References Nishimura T (2017) Potential Areas for Improvement of GMP Compliance APEC Harmonization center (2018) Center of Excellence Overview http://www. Assessment: Suggestion from Japan Pharmaceuticals Manufacturers nifds.go.kr/apec/content/view.do?contentKey=288&menuKey=318 th Association (JPMA). Powerpoint presented at the 6 Asia Partnership APEC RHSC Vision 2020 (2010) A Strategic Framework: Regulatory Convergence Conference of Pharmaceutical Associations (APAC). http://apac-asia.com/ for Medical Products by 2020. http://mddb.apec.org/documents/2011/MM/ achievements/6th_apac.html AMM/11_amm_004att1.pdf Patel P, McAuslane N, Liberti L, Connelly P (2017) Facilitating the review of new ASEAN Variation guidelines for pharmaceutical products (2013) http://www.hsa. medicines through risk-based evaluations: How can a stratification process gov.sg/content/dam/HSA/HPRG/Western_Medicine/Overview_Framework_ be utilised to achieve an effective use of resources, Workshop Report, Centre Policies/Guidelines_on_Drug_Registration/ASEAN%20Variation% for Innovation in Regulatory Science (CIRS) 20Guideline%20for%20Pharmaceutical%20Products%207.2%20clean%20draft. PIC/S Brochure 2016, https://www.picscheme.org/layout/document.php?id=692. pdf PIC/S Members Official website. https://www.picscheme.org/en/members Asia-Pacific Economic Cooperation (APEC), Member Economies (2017) Taiwan regulation. http://regulation.cde.org.tw/. Notice No. 1041409729 (2015). https://www.apec.org/About-Us/About-APEC/Member-Economies http://regulation.cde.org.tw/doc_data_display?sid=2398&doctype2= Australia-Canada-Singapore-Switzerland (ACSS) Consortium (2017) https://www. Tominaga T (2013) The ICH, the GHTF, and the future of harmonization initiatives. tga.gov.au/australia-canada-singapore-switzerland-acss-consortium Therapeutics Innov Regul Sci 47:572 CFDA Order No. 35 (2017) "Decision on Adjusting the Management of Imported WHO CPP Scheme in today’s regulatory environment – is it time for change Drugs Registration” (October 2017). http://www.sfda.gov.cn/directory/web/ (2015). WHO drug information Vol. 29, No 4 WS01/CL0053/178363.html WHO Certification Scheme on the quality of pharmaceutical products moving in Deloitte & Touche LLP (2017) Fostering Biomedical Innovation & Excellence: international commerce: Questions and Answers (2016). WHO Drug Collaborating to enhance access to innovative medicines in Singapore Information Vol. 30, No. 3 EMA-FDA pilot program for parallel assessment of Quality-by-Design applications: WHO collaborative procedure in the assessment and accelerated national lessons learnt and Q&A resulting from the first parallel assessment (2013) registration of pharmaceutical products approved by stringent regulatory http://www.ema.europa.eu/docs/en_GB/document_library/Other/2013/08/ authorities (2017) WC500148215.pdf WHO Guidance on Good Practices for desk assessment for compliance with EU-US mutual recognition of inspections of medicines manufacturers enters Good Manufacturing Practices, Good Laboratory Practices and Good Clinical operational phase (2017) http://www.ema.europa.eu/docs/en_GB/document_ Practices for Marketing Authorization of Medical Products (2017) library/Press_release/2017/10/WC500237909.pdf WHO Good Regulatory Practices (2016) Guidelines for national regulatory Government of Canada (2017) Guidance Document: Use of Certificates of authorities for medical products Suitability as supporting information in Drug Submissions https://www. Wong G- BN, Lim J-CW (2003) Drug regulation by Singapore’s health sciences canada.ca/en/health-canada/services/drugs-health-products/drug-products/ authority: the role of the Centre for Drug Evaluation. Drug Info J 37:15(S)– applications-submissions/guidance-documents/chemical-entity-products- 25(S) 2003 0092-8615/2003 quality/guidance-document-use-certificates-suitability-supporting- information-drug-submissions.html Haydock I (2010) Singapore looks beyond its shores. Regulatory Affairs J Pharma 21(4):229–230 Hong Kong Drug Office (2017) Guidelines on Application for Change of Registered Particulars of a Registered Pharmaceutical Product. http://www. drugoffice.gov.hk/eps/do/en/pharmaceutical_trade/guidelines_forms/ lcopGuide.html HSA Therapeutic Products Guidance Page 42 of 166 (2016). http://www.hsa.gov. sg/content/dam/HSA/HPRG/Western_Medicine/Overview_Framework_ Policies/Guidelines_on_Drug_Registration/DR_Guide_2016/ DR%20guide%202016%20final/Guidance%20on%20Therapeutic%20Product% 20Registration%20in%20Singapore%202016.pdf HSA Therapeutic Products Guidance Page 51–55 (2016). http://www.hsa.gov.sg/ content/dam/HSA/HPRG/Western_Medicine/Overview_Framework_Policies/ Guidelines_on_Drug_Registration/DR_Guide_2016/DR%20guide%202016% 20final/Guidance%20on%20Therapeutic%20Product%20Registration%20in% 20Singapore%202016.pdf HSA gains international acceptance as a member of the ICH (2017). http://www. hsa.gov.sg/content/hsa/en/News_Events/Press_Releases/2017/hsa-gains- internationalacceptanceasamemberoftheinternationalcoun.html HSA International Accreditation, Liaisons and Agreements (2001) http://www.hsa. gov.sg/content/hsa/en/Health_Products_Regulation/Manufacturing_
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