GMP News - Regulatory Affairs

The submission of a variations application for a marketing authorisation often includes the submission of stability data. This is particularly applicable to cases in which critical quality characteristics of the medicinal products are concerned. A new EMA Guideline sets rules to the requirements on different variations scenarios. Read more here.

Companies who want an authorisation for generic tablets or capsules in the USA should consider certain requirements with regard to the physical attributes of these dosage forms. The provisions can be found in a FDA Guidance for Industry recently published. Read more here.

Biopharmaceutical firms are calling for a global effort to decrease their heavy post-approval change filing burdens that would clarify and harmonize change classification and submission requirements on a risk-based foundation. Read on.

Since the 1st of January 2010, only electronical submissions for marketing authorisations within the centralised procedure can be accepted. A few significant details about the procedure and the standards have been  recently changed. Read more here about the current requirements for the electronical submission of  dossiers.

What do applicants for marketing authorisations of generic products absolutely have to observe is laid down in a FDA Guidance on fees and procedural issues within the framework of the Generic Drug User Fee Act (GDUFA). Read more on the topic.

How to apply for a second or third additional Certificate of Suitability for the same API? The EDQM has released a guideline on the topic. Read more about how the so-called "Sister File" procedure works.

The FDA has published a document with 30 questions and answers to clarify some issues regarding the stability testing of generic products. Read more here about the stability data required for ANDAs.