The European Medicines Agency (EMA) published ICH guideline Q4B Annex 14 to note for evaluation and recommendation of pharmacopoeial texts for use in the ICH regions on bacterial endotoxins tests". Read more.
Since the introduction of the Generic Drug User Fee Act (GDUFA) all Drug Master File (DMF) holders are required to pay a fee and the DMFs have to undergo a completeness assessment. The FDA has now published a list with all DMFs which meet these criteria. Read more.
The United Kingdom has established a webpage about the Directive on the prevention from falsified medicines ("Falsified Medicines Directive"). Read more here about the information contained on this page and learn why it is important to visit it.
The terms qualification, requalification and monitoring are often mixed up, especially if the somewhat different language from ISO standards is used in the GMP environment. This can lead to misunderstandings that may result in problems. Read more.
Since the nineties, cleaning validation has been one of the main validation topics discussed by the pharmaceutical industry and API manufacturers. Because of growing globalisation, countries in East Asia (Tiger States and Panther States) have also become interesting as consumer countries of APIs and/ or medicinal products. What about requirements on cleaning validation there? Read more here.
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.
The EMA has published a Q&A document to clarify the questions still open with regard to the "detailed guidelines on procedure issues and the classification of variations" associated to the Variations Regulation. Read more here in the News.
The revision of Chapter <854> on IR Spectroscopy proposed by the USP contains new provisions on the acceptance criteria for the validation of this method. Moreover, a new Chapter <1854> will provide theory and practice of Mid Infrared Spectroscopy. Read more in the News.
In our News from 11 September 2013, we reported about FDA's initiative to identify production sites according to a uniform system. The topic seems to be crucial for the FDA as it has now released the draft of a "Guidance for Industry" entitled ... Read on.
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.
Which APIs stability information is required for a US Drug Master File within the marketing authorisation application of generic product? Read more about what DMF holders and applicants have to take into consideration in this context.
Referring to the increasing need of Cellular and Gene Therapy products, the FDA published a daft guideline "Considerations for the Design of Early-Phase Clinical Trials of Cellular and Gene Therapy Products". More details can be found here.