Masterarbeit

International cooperation among Drug Regulatory Authorities

Birte Weselmann (2017)

Summary
Language: English
It is obvious that the similar missions and tasks of the large number of Drug Regulatory Authorities worldwide as a minimum imply interesting opportunities for cooperation, to avoid duplication of efforts and optimize use of resources. Furthermore the trend towards globalization in the pharmaceutical industry, the rapidly emerging technologies and possible future health threats and emergencies like the recent Ebola and Zika outbreaks somehow imperatively require authorities to strengthen cooperation.
And indeed the global picture of regulatory cooperation shows a number of different initiatives among Drug Regulatory Authorities. These include bilateral arrangements like EMA-FDA cooperation and regional initiatives like the European Medicines Regulatory Network (EMRN), the Association of Southeast Asian Nations Pharmaceutical Product Working Group (ASEAN PPWG), the Asia-Pacific Economic Trade Life Sciences Innovation Forum Regulatory Harmonization Steering Committee (APEC LSIF RHSC), the Gulf Central Committee for Drug Registration (GCC DR), the Zambia, Zimbabwe, Botswana, Namibia Transmission project (ZaZiBoNa), the Southern African Development Community (SADC), the East African Community Medicine Registration Harmonization (EAC MRH), the African Medicines Registration Harmonisation (AMRH), the Pan American Network for Drug Regulatory Harmonization (PANDRH). Furthermore there are several cross-regional initiatives, such as the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH), the International Conference of Drug Regulatory Authorities (ICDRA), the International Generic Drug Regulators Programme (IGDRP), the International Pharmaceutical Regulators Forum (IPRF), the Pharmaceutical Inspection Co-operation Scheme (PIC/S) and the International Coalition of Medicines Regulatory Authorities (ICMRA).
They all claim ambitious aims with different priorities, but the main areas of cooperation are regulatory harmonization or convergence, information sharing and discussion and work-sharing including avoiding unnecessary duplication of work.
Political and economic arrangements or treaties, strategic coordination by a leading initiative, binding agreements and involvement of other stakeholders shape the initiatives and influence their prospects of success.
Not all current economic, societal and political trends favour the success of existing initiatives or promote the start of new ones; nevertheless, with respect to the current global picture of regulatory cooperation it is reasonable to assume that national Drug Regulatory Authorities will, in their own and societal interest at large, keep some commitment to contribute to the creation of a regulatory environment in which safe and efficacious medicinal products are made available to the global public in the timeliest and most efficient way.
Pages: 51