EMA Report Emphasizes Need for Coordinating International Regulatory Initiatives

Regulatory NewsRegulatory News | 13 October 2016 |  By 

The European Medicines Agency (EMA) on Thursday released what it says is the first comprehensive overview of international regulatory initiatives, calling attention to the need for greater coordination across international regulatory efforts.

EMA says the report was developed on behalf of the International Coalition of Medicines Regulatory Authorities (ICMRA) to "provide a general overview of multi-project initiatives in which multiple regulators were involved."

Background: ICMRA

ICMRA was created following a series of discussions stemming from a session at the 65th World Health Assembly in Geneva, Switzerland in 2012 to improve coordination among regulators on a global level.

ICMRA members include EMA, the European Commission and regulators from a number of European countries, as well as Australia, Brazil, Canada, China, Japan, Korea, Mexico, New Zealand, Nigeria, South Africa and the US.

Report: Connecting the Dots

According to EMA, its goal in mapping international regulatory initiatives is to "raise awareness of ongoing international regulatory activities, help establish a basis for a more strategic coordination to avoid duplication of efforts, and identify possible gaps."

"The mapping activities led by EMA are a first attempt to produce a global overview of current international initiatives in key areas for medicines regulators, which is a prerequisite for achieving more effective coordination of regulators worldwide," EMA writes.

In total, EMA identified a total of 20 multinational initiatives, each undertaking multiple projects within the field of human medicines.

International Regulatory Initiatives
International Council for Harmonisation (ICH)International Pharmaceutical Regulators Forum (IPRF)
International Coalition of Medicines Regulatory Authorities (ICMRA)Pharmaceutical Inspection Co-operation Scheme (PIC/S)
International Generic Drug Regulator's Programme (IGDRP)World Health Organization/Essential Medicines and Pharmaceutical Policies (WHO/EMP)
Council for International Organizations of Medical Sciences (CIOMS)Organization for Economic Co-operation and Development (OECD/Health Division)
International Regulators Consortium InitiativeEuropean Medicines Regulatory Network (EMRN)
European Directorate for the Quality of Medicines & Healthcare (EDQM)African Medicines Regulatory Harmonization programme (AMRH)
East African Community Medicines Registration Harmonization Project (EAC/MRH)Southern African Development Community/Pharmaceutical Harmonisation Initiative (SADC)
Zambia, Zimbabwe, Botswana, Namibia Transmission Project (ZaZiBoNa)Ibero-American Medicines Authorities Network (EAMI Network)
Pan-American Network for Drug Regulatory Harmonization (PANDRH)Association of Southeast Asian Nations Pharmaceutical Product Working Group (ASEAN PPWG)
Asia-Pacific Economic Cooperation/Life Sciences Innovation Forum/Regulatory Harmonization Steering Committee (APEC LSIF RHSC)Gulf Central Committee for Drug Registration/Harmonization Initiative (GCC-DR)

However, despite the "myriad of initiatives" identified in the report, EMA says it found "no strategic coordination," among them.

"Similar initiatives often have differently worded objectives which frequently overlap. There are some recurrent objectives e.g. information sharing and harmonisation, but they usually apply to different regions or thematic areas."

According to EMA, these overlaps "hinder the provision of a comprehensive overview and comparison of various initiatives," while leaving "gaps and critical areas that are not yet addressed by any international initiative."

For instance, for pharmacovigilance, which the report highlights as a potential priority area where ICMRA could have the most positive impact, EMA says it identified 18 different initiatives that covered everything from the technology used for reporting, collection, management and analysis of adverse events to developing harmonized guidelines and policies for pharmacovigilance activities.

Here EMA says efforts are stunted due to "a lack of mutual awareness," and that despite the high number of initiatives, one major area—using big data and "real world evidence" in pharmacovigilance—is overlooked.

EMA, Connecting the Dots – Towards global knowledge of the international medicine regulatory landscape: mapping of international initiative s


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