Topics The 4th Symposium on Japan-India Medical Products Regulations" was held Mature discussion on drug regulation between Japan and India (Japan-India) and further development into an international cooperation scheme
On February 5, 2020, the "4th Japan-India Symposium on Medical Product Regulations" was held at Bellesalle Tokyo Nihonbashi (Chuo-ku, Tokyo), in line with the Memorandum of Understanding (MOU) "Cooperation Memorandum on Framework for Dialogue and Cooperation on Medical Product Regulations" signed in 2015 between the Ministry of Health, Labor and Welfare (MHLW) and the Indian Ministry of Health and Family Welfare and Central Drug Standards Control Organization (CDSCO). The symposium was the fourth in 2020, and the first public-private joint symposium has been held since 2016.
Scene at the venue
The symposium was attended by five members from the Indian administration, including Mr. V.G. Somani, Director General, Central Drugs Standards Control Organization (CDSCO), Mr. Hemant G. Koshia, Gujarat State Regulatory Authority, and Ms. Mona K C Khandhar, Minister, Embassy of India. From the Japanese administration side, five people including Mr. Hideki Tarumi, Director General, Pharmaceuticals and Consumer Health Bureau, Ministry of Health, Labour and Welfare, Mr. Naoyuki Yasuda, Director, Office of International Pharmaceutical Regulations, and 11 people including Mr. Yasuhiro Fujiwara, President, Mr. Kenichi Hayashi, Director, Ms. Junko Sato, Director, International Division, Ms. Mari Johya, Section Chief, and Ms. Mika Togashi, Chief Specialist, Pharmaceutical and Medical Device Agency (PMDA), Japan. The event was attended by 11 participants. From the industry, Sh. Udaya Bhaskar, Chairman of Pharmexcil (Pharmaceutical Export Promotion Council of India), 29 executives of the International Committee including Mr. Tadaharu Goto, Chairman of the Pharmaceutical Manufacturers Association of Japan (PMAJ), Mr. Masaomi Akana, Chairman of the International Committee, and others, 9 participants from local companies, and Mr. Mika Togashi, Senior Specialist, Japan Federation of Medical Devices Industries (JFMDA). (JFMDA), 24 participants including Mr. Nobuyoshi Ishii, Executive Director of JFMDA, 6 participants including Mr. Kunihiko Suzuki, Vice President of Forum for Innovation in Regenerative Medicine (FIRM), 3 participants including Mr. Masakane Hayakawa of Japan Generic Pharmaceutical Association, and 47 general participants, totaling 140 people.
The agenda included Opening Remarks and Keynote Speeches by Japanese and Indian regulators and industry in the morning, followed by Part A (Pre- and Post-marketing Clinical Trial Requirements for Innovative Drugs), which featured presentations on the latest trends in clinical trial rules in Japan and India, which are attracting attention, and lively discussions. The presentations and lively discussions were followed by Part A (Pre- and Post-marketing Clinical Trial Requirements for Innovative Drugs). In the afternoon, Part B (Regulations for medical devices), Part C (Regulations and latest developments for generic drugs), and Part D (Regulations and latest developments for regenerative medicine products) followed. This report focuses mainly on the presentations related to Part A and pharmaceuticals.
VIPs attending the symposium.
Opening Remarks
Mr. Hideki Tarumi, Director-General, Pharmaceuticals and Consumer Health Bureau, Ministry of Health, Labour and Welfare
Japan and India concluded a memorandum of understanding on cooperation in the field of pharmaceutical regulations in 2015 and have held symposiums since 2016 to deepen mutual understanding and discuss measures for improvement. We hope to continue our discussions to promote regulatory harmonization in both countries. With respect to each theme of the symposium, especially new drugs, as clinical development becomes increasingly globalized, it is important that innovative new drugs can be delivered to patients around the world faster and more safely through efficient development methods. We look forward to the early implementation of exemptions for conducting additional clinical trials in India for drugs approved in Japan, and the promotion of international regulatory harmonization discussions such as the International Conference on Harmonization of Pharmaceutical Regulations (ICH), the Pharmaceutical Inspection Cooperation Scheme (PIC/S) and the Pharmaceutical Inspection Cooperation Agreement (PIC/I) by Japan and India.
Mr. Mona K C Khandhar, Minister (Economic & Commerce), Embassy of India
Since the signing of the Memorandum of Understanding for cooperation in the field of pharmaceutical regulations in 2015, tremendous progress has been made in the areas of pharmaceuticals and medical devices through exchange of views between the two countries through symposia. India has learned a lot from Japan. I hope that today's symposium will also be a success so that we can deliver better medicines to our patients.
Mr. Tadaharu Goto, Chairman, Pharmaceutical Manufacturers Association of Japan
Since the signing of the Memorandum of Understanding for cooperation in the field of pharmaceutical regulation in 2015, both countries have been talking about regulatory harmonization, and I am aware that the results of these discussions are gradually emerging. The number of international collaborative trials has been increasing in recent years, and we expect Asian trials to be particularly active in the fields of oncology, respiratory diseases, and dementia. In order to deliver innovative drugs to patients in Asia, close collaboration with India and other Asian countries is essential. The Pharmaceutical Manufacturers' Association of Japan (PMAJ) considers global clinical trials as one of the best practices to bring innovative drugs to patients as quickly as possible, and is committed to promoting their implementation. I hope that this symposium will lead to a lively exchange of opinions that will help to build a good relationship between Japan and India.
Mr. Mihir Raja, Otsuka Pharmaceutical India Pvt.
Mr. Somani is also working on commitments, such as exemptions for clinical trials in India, issuing a new policy on clinical trials, and so on. Somani has also made commitments, such as exempting clinical trials in India and issuing new policies on clinical trials. The industry is very pleased with this trend and would like to further support the next steps in the cooperation between the two countries.
Keynote Speeches
Latest trend of pharmaceutical, medical device regulation, and international cooperation of India
Mr. V.G. Somani, Drugs Controller General, CDSCO
We are grateful for the mutual understanding that has been fostered by holding these Japan-India symposiums each year. CDSCO is primarily focused on (1) providing high-quality, affordable drugs and medical devices to the country, (2) improving the business environment by developing regulations, and (3) moving forward with what is in the best interest of patients and consumers in line with their The New Drug and Clinical Trial Rules, which were revised in 2019, include the following The New Drug and Clinical Trial Rules, which were revised in 2019, select products for the expedited review system based on the severity, rarity, and prevalence of the target disease, allowing the use of pre-application consultations, etc. Currently, we are actively implementing reforms in cooperation with other countries, and have concluded a basic agreement (MOU) with Japan. In terms of collaboration, we are looking for ways to mutually utilize the review and approval process, share GxP (Good x Practice), promote understanding of Indian pharmacopoeias, and build capacity (strengthen inspections and safety monitoring). By cooperating with Japan, PMDA is particularly interested in improving the review, PV, and clinical trial environment.
Latest trend of pharmaceutical and medical device regulation, and international cooperation of Japan
Mr. Kenichi Hayashi, Director, Pharmaceuticals and Medical Devices Agency (PMDA)
PMDA is working on the "4 Fs" as priorities.
- Patient First
- A patient engagement study working group (WG) was established in May 2019 with the aim of understanding what patients want and incorporating this into our work.
- Access First
- We are working on international collaboration and cooperation to balance maximizing efficacy and minimizing risk, and to optimize patient access.
- Safety First
- Quality control needs to be thoroughly implemented to ensure safety; PIC/S promotes quality control through harmonization of Good Manufacturing Practice (GMP) regulations and inspections, and we would like to share the experience of Japan's accession to PIC/S with India.
- Asia First
- We hope that the Asian countries will work together to create a strong cooperative relationship, not only because of geographical proximity, but also because of similarities in various factors. We will also utilize the Asian Network Meeting to promote regulatory harmonization and joint international clinical trials in Asia. This will encourage the provision of new drugs to patients around the world, beyond Asia.
Part A. Clinical Study Requirements on Innovative Products in Pre and Post Marketing Phase
Clinical trials and regulatory supports for innovative drug development in Japan
Mr. Daisuke Sato, Examination Specialist, New Drug Evaluation Division 1, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
This section introduces the status and regulations on drug development in Japan.
- In the review process for orphan drugs, clinical data packages were composed of domestic and overseas studies, and ethnic differences were examined based on the ICH E5 guidelines.
- In Japan, through clinical trial consultation, developers and PMDA can work closely together to develop drugs efficiently; PMDA's opinion is determined based on notifications, etc., but the agency is flexible enough to respond to actual conditions and company requests. Providing development plans early through clinical trial consultation is also beneficial to the PMDA in that it can lead to a smooth review process after an application for approval is filed.
The New Drugs and Clinical Trials Rules, 2019
Mr. V.G. Somani, Drugs Controller General, CDSCO
The New Drugs and Clinical Trials Rules in India will be introduced, focusing on the recent amendments to the law.
- The definition of a new drug has been changed by the recent amendment of the law, clearly stating that monoclonal antibodies, gene therapeutic products, etc. are also treated as new drugs.
- Clarification was made regarding compensation in trials led by physicians or sponsors. In India, people of relatively low social standing tend to participate in trials, and the government considers it necessary to protect them.
- India has a mechanism to approve without clinical trial data in India on the condition that post-marketing clinical trials (Ph4) are conducted; approval is granted after signed confirmation that Ph4 is conducted, provided there are no PK/PD data or safety issues. The approval is granted to drugs and other products that have been approved in countries designated by India, such as the U.S. and Japan. In addition, Ph4 requirements may be relaxed for drugs for serious diseases or diseases with high unmet medical needs in India.
- A pre-submission/post-submission meeting system has been established to increase transparency and predictability in the drug review process. For a fee, companies can consult on development plans, including the design of clinical trials and animal studies, before submitting an application for approval.
Strategies and challenges for innovative drug development
Mr . Satoshi Kunitada, Chairman, Pharmaceutical Evaluation Committee, Pharmaceutical Manufacturers Association of Japan
The current status and future prospects of drug development in Japan will be introduced.
- The vision of the Drug Evaluation Committee is to "support technological innovation, establish supporting regulations, and bring innovative drugs to patients more quickly and efficiently through regulatory science.
- In recent years, drug development has been challenged by changes in target diseases, a shift to biopharmaceuticals, and the use of various types of clinical trials. International clinical trials are important for faster and more efficient drug development in this environment.
- The development of the E6, E8, E17, and E19 guidelines has led to efficiency reforms in clinical trials. More flexible clinical trials are possible based on the Adjustment Protocol (E20).
- In terms of the utilization of Real World Data, there have been cutting-edge attempts overseas, such as a case in which data on off-label use was compiled and led to the addition of a new indication. In Japan, for example, the efficacy and safety should be evaluated based on off-label use data stored in the Medical Information Database (MID-NET), and the possibility of expanding indications for diseases for which clinical trials are difficult to conduct should be considered. He recommended that MID-NET should also be used for drug development, including the development of pediatric dosage forms and rare diseases.
From left, CDSCO Director Somani, PMDA New Drug Evaluation Division I Review Specialist Daisuke Sato,
Satoshi Kunitada, Chairman of the Pharmaceutical Cooperative Association's Drug Evaluation Committee
Closing Remarks
Mr. Kenichi Hayashi, Director, Pharmaceuticals and Medical Devices Agency (PMDA)
We were able to exchange information on the latest regulatory systems in both countries in the field of pharmaceuticals and learned that clinical trial consultation is being enhanced in India as well. Based on today's discussion, we hope that the cooperative relationship between the two countries will further develop into an international cooperative scheme.
Mr. V.G. Somani, Drugs Controller General, CDSCO
I got the impression that the discussions at this symposium have matured. India has been participating in international platforms, such as participating in four WGs as an observer of the World Health Organization (WHO), which is a pre-application for PIC/S, and is making efforts for regulatory harmonization by holding multilateral and bilateral meetings, including with Japan. In the future, we would like to move beyond mutual understanding to the next stage of maturity with Japan, where we can make various things a reality.
Closing Remarks
After the program, a reception was held on the same floor in a friendly atmosphere from start to finish. This year's reception was co-chaired by Ms. Junko Sato, Director, International Division, PMDA, and Mr. Masaomi Akana, Chairperson, International Committee, Pharmaceutical Manufacturers Association of Japan (PMAJ), and started off with a good collaboration between the Japanese public and private sectors. Mr. Hideki Tarumi, Director General, Pharmaceuticals and Consumer Health Bureau, Ministry of Health, Labour and Welfare, gave the toast, Mr. Yasuhiro Fujiwara, President of PMDA, closed the session, and Mr. Somani, Director General of CDSCO, and Mr. Koshia, Director General of Gujarat State Regulatory Authority, also took the stage to give speeches during the session. This was his sixth time to speak at the symposium. However, his enthusiasm and expectations for the symposium remained unchanged. We started with the exchange of information, but recently the discussions have become very mature and our understanding of each other has deepened. The friendship between the Indian authorities and PMDA runs deep, and we welcome this bilateral effort."
Mr. Yasuhiro Fujiwara, President, PMDA
The following day, a meeting was held between the authorities, and I heard that results were achieved in the specifics of pre-application consultation and clinical trial exemptions, streamlining of the review process, and further progress in international cooperation toward ICH membership and PIC/S accession. In addition, due to the urgent issue of countermeasures against new coronavirus infection, which has become a pressing issue in international health, there was a series of last-minute cancellations of participation and accompanying changes in the agenda for this year's meeting. Despite such circumstances, the symposium was successfully concluded with participants from regulatory authorities, industries, related organizations, and Indian embassies in Japan gathering together at Bellesalle Tokyo Nihonbashi. The next symposium will be held in India in 2021.
Director, Gujarat State Regulatory Authority
Mr. Hemant G. Koshia
Mr. Masaomi Akana, Chairperson of the International Committee of the Pharmaceutical Manufacturers Association of Japan (PMAJ), who chaired the reception
Ms. Junko Sato, Director, International Division, PMDA
( Chika Kuwahara, India Team Leader, International Committee, Asia Section)