CPP use for Drugs Registration in Africa and Middle east

CPP use for Drugs Registration in Africa and Middle east

The Certificate of Pharmaceutical Product (CPP) is a document of the World Health Organization’s (WHO) Certification Scheme on the quality of pharmaceutical products moving in international commerce. CPP also known as CoPP establishes the status of the pharmaceutical product and of the applicant for this certificate in the exporting country.WHO developed CPP in the late 1960s with the aim to provide assurance to its members about the quality of the pharmaceutical products moving in international trade.The CPP is widely required by emerging countries such as African and middle eastern countries in new drugs’ submission processes, post-approval changes and renewal of drugs’ registrations. Some countries in middle east request its legalization by their embassy in country of origin. CPP is more and more replacing marketing authorization in country of origin in these countries and is accurately checked by health authorities as a reference document for drug approval process.For more information : http://www.who.int/medicines/areas/quality_safety/regulation_legislation/certification/guidelines/en/index1.html