Topics The 6th Japan-India Symposium on Regulation of Medical Products was held.
The 6th Japan-India Symposium on Regulation of Medical Products was held on February 1, 2023, by the Ministry of Health, Labour and Welfare (MHLW), the Pharmaceuticals and Medical Devices Agency (PMDA), the Indian Ministry of Health and Family Welfare, and the Central Drug Standards Control Organization (CDSCO). The Pharmaceutical Manufacturers Association of Japan (PMAJ), together with the Federation of Pharmaceutical Manufacturers' Associations of Japan (FPMAJ), Japan Federation of Medical Devices Industries and Associations, and Regenerative Medicine Innovation Forum, cooperated in the planning and operation of the symposium as supporting organizations. The symposium aims to improve the level of pharmaceutical regulations in both countries and to facilitate regulatory compliance by industry by sharing the latest trends in the regulation of pharmaceuticals, medical devices, and regenerative medicine products in Japan and India, as well as issues and proposals from industry, and discussing international regulatory harmonization and cooperation. In the two sessions on pharmaceuticals, (1) Regulations to Promote Fast Patient Access and (2) International Cooperation and Reliance, active exchanges of opinions between the public and private sectors took place to promote understanding. This section reports on the pharmaceutical session.
Introduction
This symposium was held in an online format, following the 5th symposium in December 2021, and was attended by more than 300 participants from both countries. In the opening session, Mr. Fumio Yamamoto, Deputy Director-General (Pharmaceuticals), Minister's Secretariat, Ministry of Health, Labour and Welfare (MHLW), gave opening remarks, referring to the importance of cooperation between regulatory authorities and industry between Japan and India. While the global situation is changing, including the recent globalization of supply chains, India's position in Japan is growing, and the supply of APIs and other products manufactured in India to the global market, including Japan, is expected to continue to expand. The supply of high quality pharmaceuticals from India is essential for gaining the trust of the world, and Japan will spare no effort to cooperate. Mr. Rajiv Wadhawan, Joint Secretary, Ministry of Health and Family Welfare, India, then stated that ensuring the quality of medicines has become a global challenge, which he hopes to achieve through regulatory harmonization and cooperation with industry in order to supply safe medicines.
Junichi Shiraishi, President of the Pharmaceutical Manufacturers Association of Japan (PMAJ), stated that while the PMAJ and its member companies are working to fulfill their mission as R&D-oriented pharmaceutical companies to create treatments and vaccines as early as possible and to ensure a stable supply of pharmaceutical products, regulatory reforms that will promote innovation between Japan and India and public-private partnerships that will contribute to improving the quality of healthcare overall are needed. He also mentioned the need for public-private partnerships that contribute to the improvement of the quality of healthcare as a whole. He also expressed his hope that the results of this dialogue will be passed on to patients around the world who are waiting for new drugs, and strongly requested that the symposium be continued in the future.
Keynote Speeches
Regulatory authorities from both countries presented lessons learned and lessons learned on regulatory flexibility and agility (Agility) in the new coronavirus infection (COVID-19) pandemic.
PMDA President Yasuhiro Fujiwara introduced PMDA's main efforts in expedited approval of COVID-19-related products, implementation of an emergency approval system, and establishment of a system for non-COVID-19-related products. International cooperation is also indispensable for such systems as expedited approval, and he mentioned the importance of the "Pharmaceutical Inspection Agreement and Pharmaceutical Inspection Cooperative Scheme (PIC/S)," which aims to improve global manufacturing of pharmaceutical products and their quality control, as well as the Multinational Research Collaboration Trials (MRCT) to enable early access for patients in Asian countries. He also emphasized the importance of further collaboration based on the experience gained through COVID-19, rather than just responding to COVID-19 alone, and that international collaboration with India, an important partner, should be rooted in the idea of working with each other promptly and transparently to meet the needs of the public. I was very impressed by his statement that international collaboration with India, an important partner, is rooted in the idea of working with each other promptly and transparently to meet the needs of the public.
Mr. V.G. Somani, Drugs Controller General of CDSCO, spoke about the importance of regulatory compliance with other countries, including Japan, the development of guidelines for urgent review and approval, and the establishment of a Special Subject Expert Committee (SEC) for vaccines, diagnostics, and therapeutics related to COVID-19. He also introduced the establishment of the Special Subject Expert Committee (SEC) for vaccines, diagnostics, and therapeutics related to COVID-19. He explained that while efforts such as the use of virtual audits, digitization of the Regulatory Process, and online application processing in emergency situations are accelerating, international cooperation is also important, and that contracts have been signed with 12 countries, including Japan, to promote alliances. In order to reduce dependence on imports, they will develop and manufacture more valuable products, strengthen the manufacturing supply base in the domestic and global markets, and become self-reliant, as well as build an ecosystem to improve access to affordable, high-quality pharmaceutical products, and simplify and digitize processes.
The Pharmaceutical Cooperative explained the current situation regarding licensing in India, where a lot of documents are required from the viewpoint of efficiency, which is a major burden when renewing licenses, and proposed extending the validity period of import licenses from 3 to 5 years, and for license renewals, which have been approved once. Mr. Somani stated that while this is a very valid need, it is necessary for the authorities to evaluate various aspects first, and that he will study the issue and provide a response. A participant from India also asked about novelty assessments and how to proceed with innovations such as new technologies, treatments, and diagnostics in the post-coronary market. Although we were not able to get a detailed answer to this question due to the different regulatory authorities, we got the impression of India's willingness to create innovations, and felt that we would like to consider not only obtaining approval but also the entire drug access process after approval again.
(1) Regulations to promote Fast Patient Access
Mr. Mineo Matsumoto of PMDA's International Affairs Department, Asia Division 1, introduced the regulatory system for early approval, highlighting special approval and emergency approval. Both of these are applied when there is no other appropriate way to prevent the spread of adverse health effects in an emergency situation. Other systems in Japan that allow for early approval of innovative drugs include expedited review, priority review, a system for designating pioneering drugs, and an accelerated approval system with conditions. He also introduced the experience of conducting clinical trial consultations and GMP site inspections remotely as part of an efficient approval review process. India is also implementing a variety of initiatives, and the participants hope to exchange information to further improve the system and make it more effective.
From the Indian side, A.K. Pradhan, Joint Drugs Controller of CDSCO, explained the new regulations issued in March 2019. The regulations also incorporate provisions to improve access to medicines in order to promote ethical and scientific clinical research and new drug development, and he explained about orphan drugs and expedited approval of unapproved new drugs. In particular, clinical trial exemptions in India are of interest to global companies and pharmaceutical association member companies. In situations where there is an unmet medical need or a serious life-threatening disease, or where no other alternative treatment is available, CDSCO will take into consideration the severity, rarity, and prevalence of the disease. Surrogate endpoints may also be considered in lieu of an efficacy evaluation, while marketing authorization may be granted when there is an unmet medical need, even if based on Phase II clinical trial data. The Pharmaceutical Manufacturers Association of Japan (PMAJ) asked the CDSCO for clarification of the regulatory decision in these cases. The Pharmaceutical Manufacturers' Association of Japan (PMAJ) considers as an issue the cases in which a Phase IV study was requested even though a Phase III study was conducted in India. The PMAJ requested the CDSCO to provide guidance to clarify the criteria for exemption, such as the number of cases, necessary evaluation contents, and evaluation materials. In response to this request, the CDSCO's PI, Dr. K. K. K., and Dr. M. K. K. were asked to provide guidance on the criteria for exemption. In response, Mr. Pradhan of the CDSCO stated that even if a Phase III clinical trial is conducted in India, a Phase IV clinical trial may be a condition for approval, depending on the characteristics of the product and the type of clinical trial that was conducted. Apart from this, we also asked how the SEC's advice would be involved in a New Drug Application (NDA) and how the SEC could streamline the pre-consultation process, and Mr. Pradhan said that the SEC's role would be clarified and that they would consider being flexible in the future.
In the discussion among the regulators, he asked whether there is any resistance from within the regulators or from industry, although he thinks that regulatory reforms that increase predictability are great. It was impressive that both the public and private sectors were able to recognize hints on how to minimize the risk of pioneering systems and to implement them without resistance. In this way, many topics that accelerated discussions were raised from various fields at this symposium, and I believe that not only the content of the presentations but also the exchange of opinions was enhanced.
(2) International Cooperation and Reliance
In recent years, the internationalization of supply chains, rapid development of new technologies, and the COVID-19 pandemic have increased the importance of international collaboration. Many of the pharmaceuticals used in Japan are imported from overseas, such as India and China, as APIs or intermediates, so problems in each country have a direct impact on the domestic supply of pharmaceuticals in Japan. International harmonization of pharmaceutical regulations and prompt and accurate information sharing on a global basis are essential.
Ms. Rubina Bose, Deputy Drugs Controller of the CDSCO, mentioned that the Indian authorities have been cooperating with authorities in various countries, mainly through initiatives at the World Health Organization (WHO) and the Japan-US-Australia-India Strategic Dialogue (QUAD), and as an observer at the International Conference on Harmonization of Pharmaceutical Regulations (ICH). He introduced his involvement as an observer at the World Health Organization (WHO) and the Japan-US-Australia-India Strategic Dialogue (QUAD), as a member of the International Conference on Harmonization of Pharmaceutical Regulations (ICH) and the International Collaboration of Medicines Regulatory Authorities (ICMRA), and his involvement in the international framework for vaccine use.
Ms. Eiko Ogata, Director, First Asia Division, International Department, PMDA, explained that the Japanese authorities have proposed guidelines for safety assessment and global clinical trials using real world data (RWD) at ICH, and that she has been working with Dr. Somani, Director General of CDSCO, at ICMRA to develop the basic concept of corona vaccines. He also introduced the basic concept of the Corona Vaccine, which he has been working on together with Dr. Somani, Director of CDSCO at ICMRA. In addition, the Japan-US-EU Three Pharmacopeias Review Group (PDG) has been conducting international harmonization activities for the test methods and drug additive articles of the European Pharmacopoeia (EP), the Japanese Pharmacopoeia (JP), and the United States Pharmacopoeia (USP). The Indian Pharmacopoeia (IPC) participated for the first time as a participant in the PDG's membership expansion program. Regulatory harmonization at the IPC is also expected in the future.
On the other hand, one of the challenges faced by pharmaceutical association member companies in India is that when an API is listed on the IPC, it is sometimes listed with specifications and test methods that differ from those of the originator. In some cases, even the originator was required to update the separately approved specifications. In this regard, the JP requested that, in addition to the JP reference, the JMA consider accepting more flexible standards and test methods compared to the IPC when there are reasonable reasons, and to provide an opportunity to exchange opinions with originators before listing an API already registered in India in the IPC. As a result, Mr. Bose said that CDSCO is already aware of these issues, and that they publish new standards on their website and solicit public comments in order to register the originator's standards when they are listed on the local market. They are planning to study and improve this process to make the approach more flexible. The CDSCO will continue to work with local pharmaceutical organizations to resolve issues in the local pharmacopoeia listing process from multiple perspectives, including the use of JPs as references.
Closing Remarks
Mr. Somani, Director General of CDSCO, concluded his remarks by stating that the regulatory process is about speed, transparency, and accountability, but more importantly, it is about "predictability. commented. He continued that in India, the Japan-India relationship is a family and a future, and he hopes that the special relationship between Japan and India will continue to grow in the future. I hope that this good relationship between Japan and India will lead to further international collaboration and fair access to medicines for patients around the world. The next 7th Symposium is scheduled to be held in 2024.
( Chika Kuwahara, India Team Leader, International Committee, Asia Section)