Reliance is key to effective access and oversight of medical products in case of public health emergencies.

INTRODUCTION: Responding to new threats and public health emergencies (PHE) creates serious challenges to regulators. The pandemic due to SARS-CoV-2 has been the catalyzer for change in global and local regulatory practices. Intensified collaboration, rapid and coordinated actions, and reliance mechanisms were key elements of the regulators' response to COVID-19 for all regulatory functions. AREAS COVERED: This article presents how collaboration and reliance among regulators were crucial tools for the regulatory responses to COVID-19, describes the reliance approaches for authorization of COVID-19 vaccines and other commodities, and the importance of reliance for other regulatory functions to avoid duplication and save resources where possible. This article also presents the results of a follow-up survey of reliance approaches in case of public health emergencies conducted between the International Pharmaceutical Regulators Programme (IPRP) members and discusses the forward-looking potential of reliance, analyzing the journey from theoretical concepts to real-life implementation. EXPERT OPINION: Regulatory reliance is an essential tool for regulators to act quickly and collectively in times of public health emergencies. Reliance approaches facilitate regulatory approvals and allow a more efficient use of resources, ultimately serving patients by facilitating earlier access to quality assured, safe and effective medicines.

Reliance: a smarter way of regulating medical products - The IPRP survey.

Introduction: A survey was conducted among national regulatory authorities' members of the International Pharmaceutical Regulators Programme (IPRP) to collect and share experiences of reliance approaches. Reliance allows formally, or informally, one regulatory authority to use assessments made by other regulatory authorities while remaining responsible for the final decision. Reliance is an essential concept to increase the efficiency of the global regulatory oversight of medical products by national regulatory authorities.Areas covered: This article describes the findings and recommendations from the IPRP survey. It shows that reliance in the area of medical product oversight is broadly accepted. The first part presents the acceptance and reasons for accepting reliance including the need for trust, then gives examples of the most common areas for reliance, and explains the difference between unilateral or reciprocal reliance. Finally, the article analyzes the lessons learned including challenges and opportunities for reliance on regulatory authorities to facilitate patient access in their jurisdictions.Expert opinion: Regulatory reliance facilitates regulatory approvals and allows to use resources in a more efficient way and ultimately serves patients by facilitating earlier access to quality-assured, safe, and effective medicines.

Measuring Progress of Regulatory Convergence and Cooperation Among Asia-Pacific Economic Cooperation (APEC) Member Economies in the Context of the COVID-19 Pandemic.

PURPOSE: Regulatory convergence and cooperation among medical product regulatory authorities are essential to delivering safe and efficacious products quickly to patients. The COVID-19 pandemic highlights the urgent need for streamlined regulatory approval processes-which can be achieved in part through regulatory convergence and cooperation-both to accelerate availability of COVID-19 vaccines, treatments and diagnostics and to maintain the availability of the existing medical products unrelated to COVID-19. METHODS: The Asia-Pacific Economic Cooperation (APEC) Life Sciences Innovation Forum (LSIF) established the Regulatory Harmonization Steering Committee (RHSC) in 2008 to advance regulatory convergence among APEC's 21 member economies. Key performance indicators (KPIs) were developed in 2018 to measure convergence. RESULTS: This paper reports survey results collected from KPI tracking in March 2020 from medical product regulatory authorities in all 21 APEC economies concerning areas of regulatory practice in which they could converge and cooperate. For example, from 2008 to 2020, there was a 14.3% increase in the number of APEC member economy regulatory authorities sharing Good Manufacturing Practices (GMP) Certificates and a 28% increase in the number of regulatory authorities accepting multisite licenses in that same period. In addition, this paper explores how APEC economies could realize a maximum level of regulatory convergence and cooperation. CONCLUSIONS: Convergence efforts within APEC can accelerate availability of medical products including that related to COVID-19 vaccines, treatments and diagnostics, while maintaining the availability of the existing medical products unrelated to COVID-19 vaccines and treatment. New KPIs and capability building are to be considered to enable a new era of innovation ushered in by COVID-19.

National GLP programmes and implication of regulatory authorities for pharmaceuticals, pesticides and other chemicals.

There are various kinds of good laboratory practice (GLP) monitoring authorities (MAs) in the world. Some countries have only one MA, while others, including Japan, have more than one MA. In addition, each MA has its own relationship with regulatory authorities (RAs), receiving authorities (RcAs) and industry based on the internal regulatory systems. There are eight GLP MAs in Japan. This number is probably the largest in the world. Efforts have been made to establish a close link among MAs and to apply and implement GLP programmes in an efficient, effective and consistent way, namely: i) interministerial meeting on GLP. It is essential to establish a system for information exchange and decision making when there are a number of MAs such as in Japan. To this end, the interministerial meeting on GLP has been set up as a means for MAs, RAs, and RcAs to share information on Organization for Economic Co-operation and Development (OECD) and foreign countries and make national decisions as a whole country; ii) joint training programme. With the goal of training inspectors and minimizing differences in inspections among MAs, a joint training programme has been started including joint visits to test facilities (TFs) and participation in evaluation committees at other MAs. One of the purposes of this training programme is to get ready for the on-site evaluation visit (OEV) of the OECD by simulating it at MAs in Japan; iii) joint translation programme of the OECD documents. To avoid unnecessary confusion due to differences of interpretation and translation of OECD documents among MAs, these have been translated into Japanese in cooperation with industry. This has also other substantial merits such as cost reduction and time saving for all stakeholders in Japan. Some countries, both members and non-members of the OECD, have also established more than one GLP MA. It is hoped that the Japanese experience can be useful to them.