The aim of the International API Inspection Programme is the cooperation of authorities in monitoring and controlling API manufacturers. Read here, by which measures an optimised bundling and efficiency enhancement of the regulatory supervision of API facilities via GMP inspections are to be reached.
While EU and FDA GMP Guidance is very similar, there are also some areas where there are known differences. It is worthwhile being aware of these differences when dealing with companies and authorities from the "other side".
In June 2018 the ICH Assembly agreed to work on a new guideline ICH M11 "Clinical electronic Structured Harmonized Protocol (CeSHarP)".
The ICH M9 Guideline has reached the consultation step. The Guideline is proposed to address Biopharmaceutics Classification System (BCS)-based biowaivers.
After considering public comments FDA received about the draft guidance on “Statistical Approaches to Evaluate Analytical Similarity” issued in September 2017 the agency decided to withdrew the proposal. The guidance was intended to provide advice for sponsors developing biosimilar products regarding the evaluation of analytical similarity between a proposed biosimilar product and the reference product.
The FDA recently released a guidance on patient experience data from patients, caregivers, clinicians and others for product development and regulatory decision-making.
There are currently massive problems with Valsartan preparations due to contamination of the active substance. But where is it coming from? And could it have been prevented?
It's official: the United Kingdom wants to remain in the EMA. This can be gathered from a recent statement by the government.
Glycerin is often used as an excipient in solid and semisolid dosage forms. For companies supervised by the FDA, comprehensive testing of the incoming excipient is mandatory. Otherwise, they risk receiving a warning letter, like an Irish pharmaceutical company recently did. The deficiencies the FDA inspectors found in the areas of quality control and quality assurance are described here.
Drug manufacturer IDT Australia Ltd. received an FDA warning letter in May 2018. It was criticised during the FDA inspection that OOS results of assay determinations had not been investigated and that a batch had been released even though three consecutive identity tests had failed. Read more about the IDT Australia FDA warning letter here.