Comparing agency guidelines with company practice
The certificate of pharmaceutical product (CPP) was implemented to accelerate the availability of new drugs in developing countries by providing evidence of the quality of products and reducing the time to market through reliance on a prior trusted analysis.
However, the CPP format, issuing process and use have not been revised since 1997 and there are significant differences among countries regarding requirements for CPP timing, terminology, and format.
In this paper published on Therapeutic Innovation & Regulatory Science journal, we compare current CPP practices versus national regulatory guidelines to inform recommendations for the efficient use of the CPP based on the needs of the modern regulatory environment.