FDA Trains Pharmaceuticals On Dossier Preparation

The Food and Drugs Authority (FDA) has trained importers and local manufacturers of pharmaceutical products on how to prepare dossiers for registration of products before they are supplied to the market.

    The training programme, on the theme "Preparation and Submission of Medicinal Product Dossiers to FDA", was designed to correct deficiencies identified in the processing of medicine registration applications that results in unnecessary delays in the process.

     Funded by the Department for International Development (DFID) of the UK, as part of efforts to ensure that pharmaceutical products on the Ghanaian market are of good quality, the programme provided vital information required for the registration of the pharmaceutical products and thus, reduces the delays associated with the process.

     The Deputy Chief Executive Officer of FDA, Mr John Odame Darkwa, who addressed the participants, noted that FDA was not happy that the required information was not provided by importers and manufacturers on basic but very important requirement that might have life threatening consequences.

     “As business people, one can understand your frustration when you are asked to provide extra information to clarify information issues related to the quality and safety of your products. In order to reduce registration time lines it is important you grasp the overview of registration requirements so you can properly advise your foreign counterparts with regards to all the necessary information that must be filled in an application to guarantee the quality and safety of your products,” he added.

     Mr Seth Seaneke, acting Head of Drug Registration and Registration, said the main objective of the course was to ensure that all products were of good quality and safe for use.
     The FDA, he said, continued to organise periodic training for the local pharmaceutical manufacturing industry to enable them to compete fairly with their foreign counterparts and expressed the hope that the workshop would make drug registration easier and faster.

     “It is very unfortunate that the registration period of three to six months can be delayed to two years because of the forth and back of the documents which are not prepared correctly. It is our hope that this training will help equip the participants to change things for the better,” he said.

Source: GNA