Wednesday, October 27, 2010

Unified drug registration law for GCC

The Gulf Today, 27 Oct 2010

A total of 48 medicines have been denied registration in the Middle East, as different health authorities in the region revised regulations and specifications for circulating pharmaceutical products.
The GCC central committee for pharmaceutical registration will implement a unified procedure of recording medicines in the region, with a set of drug registration bylaws for biological equivalence for the member countries, said a senior official at the UAE Ministry of Health (MoH).
Heading the 50th meeting of the regional body, Dr Amin Al Amiri, the executive director for Medical Practices and Licences at the MoH, said that the final draft of the new regulations have been prepared, focusing on co-operation between the GCC countries to ensure quality of the drugs.
“The unified standardising procedures will be a platform for the Gulf countries to exchange information on drugs and similar medicinal products,” he added.
“The regulations will control the movement of medicines across all the ports of the GCC, with an early pharma detection system and establishment of a common database accessible to the health sector employees,” pointed out Dr Amiri.
“The GCC committee focuses on pharmaceutical vigilance to quickly inform the member countries in the events of detecting violations medicinal products or complications related to negative side-effects of any drug,” he elaborated.
According to him, the efforts to ensure safety of the medicines supplied in the region have to be doubled through the national pharmaceutical vigilance committee. The safety food items, medical equipments and cosmetics also has to be monitored with stringent measures.
Dr Amiri, revealed, “The central GCC committee revised registration of 17 new medicinal products and completed procedures for 17 other medicines. The registration processes of 21 new pharmaceutical establishments and re-registration of some companies have also been analysed, in addition to reviewing functions of eight firms.”
“The 48 products, which were rejected registration by the GCC committee, were found not complying with the rules and conditions,” he added.

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