This training toolkit aims at providing a greater understanding of the current process, as well as, highlighting the challenges and opportunities needed to improve and modernize the regulatory procedures that will ultimately accelerate patient access to medicines.

The WHO Certification Scheme for a Certificate of Pharmaceutical Product (CPP) is an international voluntary agreement to provide assurance to countries participating in the Scheme, about the quality of pharmaceutical products moving in international commerce.

Despite the original aim of the WHO Scheme since 1997, i.e. to provide a standard process, the regulatory procedures among countries have varied significantly and different approaches and interpretations of the CPP Scheme have applied from one country to another.

This training toolkit should be used in conjunction with the current WHO guidelines and relevant local legislative requirements.