Eastern Mediterranean Drug Regulatory Authorities Conference: towards regulatory cooperation, 5–8 May 2014

The restored Roman ampitheatre in Amman Amman's multicultural historical sites will contribute to making EMDRAC 2014 a memorable eventThe WHO Regional Office is organizing an Eastern Mediterranean Drug Regulatory Authorities Conference (EMDRAC) to take place in Amman, Jordan, from 5 to 8 May 2014, under the theme of "towards regulatory cooperation".

EMDRAC was created in the early 1990s to: enhance cooperation between regulatory authorities in the Region; identify and plan capacity-building activities; and organize regional input to the International Conference of Drug Regulatory Authorities (ICDRA).

The overall objective of the EMDRAC is to promote effective regulation of medical products and the establishment of functional national medicine regulatory authorities (NMRAs) in the Region. Its specific objectives are to:

review progress made and identify challenges encountered by NMRAs in regulation of medical products and propose solutions to address these
update NMRAs about the latest global initiatives in medical product regulation and WHO’s role in this area
advocate for the creation of common standards for regulatory functions and practices in the Region
review and agree on a draft plan of action to strengthen regulatory capacity of medical products in the Region
finalize recommendations to be presented at the sixteenth ICDRA which will be held in Rio de Janeiro, Brazil, from 24 to 29 August 2014.

Effective medicines regulation promotes and protects public health. Regulation aims to ensure the quality, safety and efficacy of medical products (medicines, vaccines, diagnostics, and medical devices) through enforcement of legislation, norms and standards. NMRAs with adequate capacity, such as a legal mandate, quality management systems, human and financial resources, infrastructure and enforcement systems can efficiently play this role. Their core functions include: licensing; health technology assessment and registration of medical products; site inspection; quality control and testing; clinical trials oversight; providing independent information and controlling promotion and advertising of medical products; and monitoring adverse reactions.

Expected outcomes

By the end of the meeting, a plan of action will be developed to strengthen regulatory capacity and convergence of medical products in the Region; recommendations finalized and Member States selected to present these recommendations at the sixteenth ICDRA.

Rationale

EMDRAC is the only regional forum exclusively for NMRAs to share information and engage in issues of regional importance. The last EMDRAC was held in December 2011. It was recommended by NMRAs that one EMDRAC should be held every two years to maintain functionality of the network and collaboration among NMRAs as major stakeholders in the pharmaceutical sector of the Region.

EMDRAC meetings are best held prior to International Conference of Drug Regulatory Authorities meetings. Through ICDRA, WHO provides a platform for drug regulators to meet and discuss ways to strengthen regional NMRA collaboration. These conferences have been instrumental in guiding regulatory authorities, stakeholders and WHO in determining issues of mutual interest by sharing information of national and international importance in the area of regulation of medicines, vaccines, biomedicines and herbals.

Target audience

Two representatives from NMRAs will be invited from the 22 countries of the Region, in addition to qualified experts from related organizations. The meeting’s secretariat will comprise of WHO staff from the regional offices for the Eastern Mediterranean and Africa and WHO headquarters. In addition, representatives from relevant universities and research institutions; WHO collaborating centres; regional pharmaceutical industry association (AUPAM); pooled procurement agency (GCC); regional and international organizations (Organization of Islamic Cooperation, League of Arab States and IGAD); World Bank, European Medicines Agency, US Food and Drug Administration; NEPAD/African Union Commission; essential medicines and policy country advisors and civil society will attend.

Methodology and approach

Each participating NMRA will be required to submit updated information on the status of their national medicines regulatory authority system. The information will be consolidated and will serve as one of the background documents for EMDRAC 2014. A template for submissions will be shared with representatives in due course.

The conference will be structured by morning and afternoon sessions, including plenary, parallel and working group sessions. The working groups will contribute to the recommendations and a regional draft plan of action will be developed in anticipation of the forthcoming World Health Assembly resolution on strengthening NMRAs.

Expected outputs

Progress reviewed and challenges identified in the regulation of medical products and possible solutions recommended for the Region
Development of a regional draft plan of action to strengthen regulatory capacity of medical products
Recommendations to be presented at the sixteenth ICDRA will be agreed upon.

Language

The meeting will be conducted in English, French and Arabic with simultaneous interpretation.