The Value of the Certificate of Pharmaceutical Product in Registration of Medicinal Products

Abstract

This article reviews the value and importance of the World Health Organisation Certificate of Pharmaceutical Product (CPP) scheme. The scheme has largely streamlined a part of the registration procedure associated with imported medicines. It provides a significant assurance to regulatory authorities that imported medicines have been evaluated against rigorous and publicly-defined standards of quality, safety, and efficacy and have been approved for marketing. It also provides confirmation that the product is manufactured in accordance with the requirements of Good Manufacturing Practice.

A more effective use of the scheme may provide drug regulatory authorities with an opportunity to deploy their resources to other areas of medicines regulation to the greater benefit of the public health. Six recommendations are made regarding how use of the scheme could be enhanced to improve patients' access to new medicines more rapidly: 1. CPPs should be required at the regulatory approval stage rather than at submission of the application; 2. Regulatory agencies should develop goals to approve products within one month after receiving the CPP; 3. CPPs should be acceptable from nonsource countries, that is, a selection of issuing authorities recognized for their highly developed regulatory review processes; 4. CPPs should be accepted from recognized authorities regardless of marketing status in that country; 5. Health authorities with limited resources should consider approving the product on the basis of a CPP alone; and 6. Legalization of CPPs should not be required.