PLAIR - new FDA Guideline regulates Import of non-approved Drugs in the Run-Up to the Launch in US
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.
Classification of Dosage Forms according to the USP
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.
QP Template for IMPs manufactured in third Countries
The EU Commission has published the final Template for the Qualified Person's Declaration of Equivalence to EU GMP for IMPs manufactured in third countries. It seems that they accepted some proposals made by stakeholders in their comments. Read more.
ICH publishes New Draft Guideline on Genotoxic Impurities
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.