arv.jpg12 African countries are working on a Common Technical Document (CTD) to harmonise regulations in the production and distribution of generic drugs on the continent.

 

Representatives from pharmaceutical companies and regulatory agencies from 12 African countries and members from the World Health Organisation (WHO) headquarters in Geneva are attending a meeting in Harare expected to come up with a common technical document that will make it easier for drug manufacturing companies to distribute generic medicines in member states without going through cumbersome processes.

 

Medicines Control Authority of Zimbabwe Legal and Corporate Affairs Assistant Director, Mr. Richard Rukwata said a lengthy process is undertaken before any medicine is registered in accordance with national legislation, guidelines and WHO standards, hence the meeting.

 

A representative from the Pharmaceutical Regulatory Authority of Zambia, Mr. Bonaventure Chilinde said the document is long overdue and the introduction of the CTD will make information sharing between regulators in regional economic communities much easier.

 

National regulatory authorities have an obligation to maintain and actively improve the standards of safety, quality and efficacy of medicines that are sold to the public.

 

In Zimbabwe, the Medicines Control Authority is mandated with the task.

 

Generic drugs are produced and distributed without patent protection but must contain the same active ingredients as the original formulation.