Topics The 5th Japan-India Symposium on Medical Products Regulations" held Proactive communication for the development of Japan-India cooperation scheme in the field of pharmaceuticals
The 5th Japan-India Symposium on Medical Products Regulation" was held on December 21 and 22, 2021 online. The symposium aims to resolve various issues faced by the industry and improve pharmaceutical regulations by sharing the latest efforts by both regulatory authorities on the regulation of pharmaceuticals, medical devices, and regenerative medicine products, as well as the expectations and requests from the industry, and by discussing harmonization of pharmaceutical regulations. This Newsletter mainly reports on the Pharmaceuticals Session.
Symposium Opening Session
This symposium is organized by the Ministry of Health and Family Welfare (MoHFW), Central Drugs Standards Control Organization (CDSCO), and the Ministry of Health, Labour and Welfare (MHLW), Pharmaceuticals and Medical Devices Agency (PMDA), and is supported by the Pharmaceutical Export Promotion Council of India (Pharmexcil), Federation of Indian The event was sponsored by Pharmexcil, Federation of Indian Chambers of Commerce and Industry (FICCI), Japan Federation of Pharmaceutical Manufacturers' Associations, Japan Medical Devices Industry Association, Regenerative Medicine Innovation Forum, and Pharmaceutical Manufacturers Association of Japan (PAPMA). The event was supported by the Federation of Pharmaceutical Manufacturers' Associations of Japan, the Japan Federation of Pharmaceutical Manufacturers' Associations, the Japan Federation of Medical Devices Industry, the Japan Regenerative Medicine Innovation Forum, the Pharmaceutical Manufacturers' Association of Japan, and the Pharmaceutical Manufacturers' Association of Japan. From industry, Sh. Udaya Bhaskar, Chairman of Pharmexcil, and Junichi Shiraishi, President of the Pharmaceutical Manufacturers Association of Japan (PMAJ), participated in the discussions on the following three themes.
1. international cooperation and reliance
The Indian side introduced the current status of active collaboration with regulatory authorities around the world and their efforts in Reliance for review, etc. CDSCO is conducting expedited approval for new drugs approved and marketed in countries designated by the MoHFW by referring to overseas data. The CDSCO has been working with the MoHFWs to develop a new drug for the treatment of In addition to vaccines for novel coronavirus infection (COVID-19), the CDSCO is considering moving forward with Reliance coverage and adding additional reference countries for other new drugs. Data utilization outside India is defined in the "New Drugs and Clinical Trials (ND&CT) Rules, 2019." As for international cooperation, the participants hoped to share best practices and other information through symposiums such as this one, and to build trust among drug regulatory authorities.
From Japan's side, the significance of international collaboration in pharmaceutical regulation (International Conference on Harmonization of Pharmaceutical Regulations (ICH), Pharmaceutical Inspection Convention and Joint Scheme for Pharmaceutical Inspection and Review (PIC/S), ICMRA (International Coalition of Medicines Regulatory Authorities)), and COVID-1990 (COVID-1990). ) and the importance of international collaboration under the COVID-19 epidemic. International collaboration is becoming increasingly important due to the internationalization of supply chains, new technologies, limited resources, and pandemic response and preparedness. In addition, he introduced the latest topics such as the progress of digitalization in various areas including online clinical trials, use of wearable devices, eCTD and e-labeling, and incorporating the opinions of stakeholders including patients due to the digital transformation. The latest topics included the progress of digitization in various fields such as eCTD and E-labeling, and the incorporation of stakeholder opinions including patients. In addition, he described Japan's activities with regulatory authorities around the world in response to COVID-19, including study design for the development of next-generation vaccines, immuno-bridging studies using existing vaccines as controls, and rapid expansion of production capacity.
The need for collaboration between India and Japan, both members of ICMRA, was reaffirmed, based on the idea of not responding only to the current pandemic, but to create a New Normal in the sense of preparing for the next one and beyond it.
2. GMP and quality management
The Indian side introduced the significance of GMP, guiding principles, revision process, and joint inspections, including a case study of an accelerated inspection of vaccines and biological products under the COVID-19 epidemic, which was conducted in a hybrid format with on-site and online inspector participation and continuous monitoring, including technology transfer. The Japanese side also introduced a case study of accelerated inspections of vaccines and biological products through continuous monitoring, including technology transfer.
From the Japanese side, PMDA introduced remote inspections using ICT tools and the GMP/GCTP compliance inspection system, which PMDA has been experimenting with in conjunction with COVID-19. As a new option, "Product Category based Inspection," which is an inspection by category, has been started, and since the validity period of the certificate is 3 years, if the number of products manufactured is large, the number of inspections may be reduced compared to conventional inspections. The two countries also introduced COVID-1990, which is a new product category based on Inspection.
Both countries showed how to avoid delays in inspections while ensuring quality even under the COVID-19 epidemic.
3. latest trends in clinical trial approval requirements
Recent developments in clinical trials in India included emergency use of unapproved or investigational drugs, humanitarian use of unapproved drugs, fast-track approval under special circumstances (used for COVID-19 vaccine approval), and the new drug review process. Data utilization and fast-track approval for clinical trials conducted outside of India are described in the "ND&CT Rules, 2019," and include the following: serious or life-threatening diseases, rare diseases, diseases of particular relevance to the health situation in the Indian region, diseases for which there is an unmet medical need The rules also state that expedited approval of new drugs will be considered for serious or life-threatening diseases, rare diseases, diseases of particular relevance to the health situation in the Indian region, diseases for which there is an unmet medical need, and use for disaster or special protection.
Japan introduced its efforts to utilize overseas clinical data and ICH guidelines: from ICH E5 to E17, the goal of minimizing duplication of clinical data and expediting the availability of beneficial drugs for patients worldwide has remained consistent, and multinational clinical trials (MRCTs) have become a powerful tool. MRCTs are a powerful tool. In Japan, pharmaceutical companies and PMDA consult with each other when planning MRCTs, and appropriate evaluations are conducted during the approval review process. It was indicated that the use of MRCT data properly planned to be accepted by the regulatory authorities in each region will enable the provision of useful drugs without delay in various regions of the world in the future.
During the Q&A session, the Pharmaceutical Cooperative Association asked about prior consultation, recommended evaluation methods, and acceptability of results from Indian cases outside of India, as there are cases in which a waiver for Phase III or IV clinical trials is not accepted in India, even if an evaluation is conducted based on ICH E5. CDSCO stated that the evaluation of MRCT data based on the ICH E5 concept of the impact of ethnic differences is not applicable to all medicines, and that the evaluation of MRCT data based on the impact of ethnic differences is not applicable to all medicines, The response was that acceptance of Indian cases from outside India could be considered, but that each case should be discussed on an individual basis.
Health Insurance System 4.
Based on the Memorandum of Understanding for Cooperation on the Framework for Dialogue and Cooperation on Regulation of Medical Products signed in 2015 between the MHLW and MoHFW/CDSCO, we have been holding joint public-private symposia since 2016. In light of the serious spread of COVID-19 infection in India, the event was postponed slightly from the original schedule, but it was successfully held for the fifth time. In his closing remarks, CDSCO Director Somani said, "Since this symposium was held online, we may not have been able to discuss as much as face-to-face due to network interruptions and congestion, but we were able to learn from each other and learn about the latest information, even during the COVID-19 epidemic. However, we were able to learn from each other and learn about the latest information, even during the COVID-19 epidemic, and it was very meaningful. We would like to hold such a symposium every year to build a system of cooperation; it is like one family. Mr. Fujiwara, President of PMDA, commented, "We have established a foundation for continued collaboration. Based on the discussions, we would like to further develop the bilateral cooperation and make it an international scheme. I hope that this symposium will be an opportunity to deepen our cooperative relationship and resolve our respective issues."
The symposium was followed by a bilateral meeting between the regulatory authorities of the two countries, which resulted in the achievement of the long-requested streamlining of the parallel review of new drug applications (NDAs). Until now, the review in India had to be conducted step by step through Step 1 (new drug approval), Step 2 (import registration), and Step 3 (import approval), but as a result of ongoing discussions since the last bilateral meeting on streamlining the review process, these three steps are now being conducted simultaneously. However, the Pharmaceutical Manufacturers Association of Japan (PMAJ) had requested that Steps 1 through 3 be centralized into a single procedure, since similar documents must be submitted to different departments in charge and there are sometimes difficulties in the timing of submission in terms of application strategies. During the meeting of the two countries, it was mentioned that guidance will be issued in the near future to consolidate Steps 1, 2, and 3 for parallel review, and we will continue to closely monitor this trend. The parallel examination has been continuously discussed among the authorities, and improvements have been achieved. The industry reaffirmed the importance of following up on the process of improving regulations, including checking the status of operations on the ground and making specific proposals for solutions.
As online holding of various conferences is becoming the New Normal, the same trend is taking place at symposiums. We will continue to devise ways for efficient public-private dialogue on a global scale. We will also consider what we can do in the future as a pharmaceutical industry based on good trust between regulatory authorities, and propose strategic advocacy plans to improve the local business environment, including resolution of pharmaceutical regulatory issues. The next public-private symposium is scheduled for early February 2023.
( Chika Kuwahara, India Team Leader, International Committee, Asia Section)