GMP News - Pharmaceutical Development / Clinical Trials / GCP

The FDA has published a new Guidance for Industry and FDA Staff: "Qualification Process for Drug Development Tools". Read more.

The scope of the FDA/EMA initiative on GCP inspections will be expanded to include inspections for generic marketing applications. Read more.

EMA and FDA published a joint report on the pilot program on Quality by Design (QbD) applications. Read more.

Under certain circumstances unapproved bulk or finished products can be imported in the United States before granting the marketing authorisation. For this purpose the FDA recently described a new standardised approach in a draft of a "Guidance for Industry". What pharmaceutical companies have to consider prior to launching their products in the United States you can read here.

The USP divides the pharmaceutical dosage forms into 5 groups and wants to elaborate new General Chapters to depict the quality and performance requirements specific to each of these 5 dosage forms. The current status of implementation is addressed in an interesting article of the Pharmacopeial Forum. Read more.

The U.S. Food and Drug Administration FDA has published two new Question and Answer Documents on Investigational Drugs. Read more.

A new ICH draft guideline on genotoxic impurities in APIs and medicinal products should help compensate shortcomings in existing regulations on the topic. The requirements of this guideline also concern medicinal products which are already available on the market. Read more here.