GMP Problems cause the Suspension and Withdrawal of further CEPs

GMP compliance problems identified during inspections resulted in the suspension and withdrawal of further CEPs. Go here to read more.


New FDA Guidance on the Development of Transdermal Systems

The new FDA draft Guidance for Industry "Residual Drug in Transdermal and Related Drug Delivery Systems" calls for a major reduction in residual drug substances in transdermal systems following application. Read more here.


PDA published Technical Report No. 50, Alternative Methods for Mycoplasma Testing

The PDA published the Technical Report No. 50, Alternative Methods for Mycoplasma Testing to help your analytical lab feel confident in the use of alternative methods. More details can be found here.


FDA, EMA and TGA Inspection Programme with impressing Result

The international pilot programme for conducting GMP inspections at API manufacturers is an impressive success. The pilot programme's provisional results were summarised in the interim report on 23 September. Find out more.


FDA drafts Guidance on the Qualification Process for Drug Development Tools

The FDA has published a Draft Guidance for Industry: Qualification Process for Drug Development Tools. Read more.


EMA Discussion Paper on intravenous Products with poorly resolvable APIs

End of September the European Medicines Agency (EMA) issued a reflection paper on the development of intravenous medicines for which micellar systems are used to improve the dissolubility of poorly resolvable APIs. Read more here.


WHO starts Pilot Programme for pre-qualifying APIs

The World Health Organisation (WHO) started a new pilot programme for pre-qualifying pharmaceutical APIs. This programme completes the already existing pre-qualification programme for medicinal products. Find out more here.


FDA provides Tips for Inspections

On its Medicinal Devices website the FDA provides -very succinct - tips regarding the course of an FDA inspection. This document can be recommended for pharmaceutical companies as well. Read more here.


FDA: New Guidance on Investigational New Drug Applications (INDs)

The FDA has published a draft Guidance for Industry on Investigational New Drug Applications (INDs) - Determining Whether Human Research Studies Can Be Conducted Without an IND for comment purposes. Read more.


EMA Management Board adopts new Policies

The European Medicines Agency's (EMA) Management Board adopted a number of important policies at its 68th meeting. Read more.


FDA Inspection Reports: What is what?

We are asked about the different inspection reports of the US-American health authority FDA (US Food and Drug Administration) again and again. In this newsletter, we would like to present the three most important documents to you. Read more.


GMP and Quality Regulation in Japan

Most people are not aware that the Japanese Pharmaceuticals and Medical Device Agency's (PMDA) website is well designed and provides a good overview about the requirements in English language. Click here to read more.


The APIC revises the "ICH Q 7 How to do" Document

The APIC's "How to do" Document is one of the most important documents for the interpretation of the GMP requirements for API manufacturers defined in the ICH Q7 Guide. This document was recently revised. Read more here.


Clinical Trials: FDA publishes final Rules for Safety Reporting

The FDA is issuing final regulations addressing the safety reporting requirements for investigational new drug applications (INDs) found in 21 CFR part 312 and for bioavailability and bioequivalence studies found in 21 CFR part 320. Read more.


New Biological Applications (BLA) - The Future of Pharmaceuticals

Pharmaceutical Technology published a report about the recent market trends and indicate the likely future direction of the pharmaceutical and biopharmaceutical industries. The reports compare past and current data and give an outlook for the future development. More you can find here.


Variations Regulation: how to classify special Changes

The Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human, CMD(h) has updated their Q&As on Variations according to Commission Regulation (EC) 1234/2008. A question was added on the classification of special changes. Read more.


Will FDA join PIC/S this Year?

Probably before the end of the year, the FDA will become a member of the Pharmaceutical Inspection Cooperation Scheme (PIC/S). Now does this mean that the FDA will not perform any more inspections in PIC/S member states? Read more.


ICH Q10: What European Inspectorates will look for

The MHRA has published a set of FAQs regarding Quality Risk Management (QRM). These questions and the respective answers give a good overview and indication on how EU Inspectorates will be inspecting and enforcing QRM elements with regard of the ICH guidelines Q8, Q9 and Q10. Read more.


Non-Investigational Medicinal Products in CTAs: Results published of Public Consultation

A set of answers has been published by the EU Commission on the public consultation on the draft guidance - Requirements for non-investigational medicinal Products in CTA Submissions. Read more.


Rx-360 receives Approval from FTC and exhibits at CPhI Tradeshow

The Rx-360 Consortium held a meeting at Merck KGaA in Darmstadt. Ms. Joanne Lewers, Partner at Drinker Biddle & Reath, the consortium's Legal Counsel and Secretary, announced that the U.S. Federal Trade Commission (FTC) has provided a positive advisory opinion pertaining to the organization's shared auditing programs. You will find more here.


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