Annex 1: European Commission Publishes Revised Document

On 20 February, the European Commission published the long-awaited revision of Annex 1 Sterile Manufacturing of the EU GMP Guideline. The document is now entering a timely limited commentary phase.


CBD is controlled as a medicine in Finland

The Finnish Medicines Agency (Fimea) recently stated that Cannabidiol (CBD) is controlled as a medicine in Finland.


Warning Letter: FDA criticizes Supplier Qualification

Supplier Qualification and the respective contracts in outsourcing activities are always hot topics in inspections, as a recent FDA Warning Letter shows.


Are Nickel-Plated Components Allowed in the GMP Area?

 The nickel plating of surfaces is a good and high-quality method to protect components or surfaces from corrosion. At the same time, the question is repeatedly asked whether components treated in this way may be used in the GMP area. Read more here.


Medical Devices Warning Letters Statistics for Fiscal Year 2019 - CAPA again "Front-Runner"

We regularly analyse the deficiencies identified in FDA Warning Letters relating to medical products. The title for the analysis of the last fiscal year 2018 was: "Medical Device Warning Letters - Fiscal Year 2018 - CAPA no longer in 1st Place". Now, what is the situation for Fiscal Year 2019 (1 October 2018 - 30 September 2019)?


Clinical Trials Regulation Questions & Answers Version 2.3

The European Commission (EC) published an updated Version 2.3 of the Questions & Answers relating to the Clinical Trials Regulation.


FDA publishes Questions and Answers on Pathogen Reduction in Blood Components

With their new questions and answers paper, the FDA wants to provide further information on the implementation of pathogen reduction techniques for blood establishments.


Second Revision of FDA Guidance Microbiology Data for Systemic Antibacterial Drugs

FDA published the second revision of their Guidance for Industry "Microbiology Data for Systemic Antibacterial Drugs -Development, Analysis, and Presentation" to define the requirements on a overall microbiology development program for such products.


Information on the Medical Devices Regulation

The application of the Medical Devices Regulation (2017/745, MDR) as of 26 May 2020 is approaching. Find out more about the MDR environment.


How to authorize a Combination Product in the USA?

In the USA, combination products are regulated independantly.  A draft document from the FDA entitled "Principles of Premarket Pathways for Combination Products" describes the ways in which marketing authorisations are granted in the USA and how the various Centers interact.


When does the FDA announce the Inspection of a Medical Device Manufacturer?

With the entry into force of the FDA Reauthorization Act (FDARA) in August 2017, sections on the inspection of medical device manufacturers in the USA and abroad also became effective. A draft document from the FDA on inspections of medical device manufacturers has been issued for some time now to further harmonize and interpret the changes.


FDA´s Advice for Sponsors of Adaptive Design Clinical Trials

The FDA published a new guideline on Adaptive Design Clinical Trials for Drugs and Biologics.


ICH E9 Addendum adopted

The ICH E9(R1) Addendum to defining the appropriate Estimand for a Clinical Trial / Sensitivity Analyses reached Step 4 of the ICH Process.


Endotoxin and Pyrogen Testing - Challenges for Biotechnological and Biopharmaceutical Products

The introduction of alternative methods as, e.g., the Monocyte Activation Test, is a challenge for many laboratories.


Second Chapter of ECA's Microbiological OOS/OOL Guideline announced for May

The ECA's Pharmaceutical Microbiology Group has announced the second chapter of their Guideline on handling microbiological deviations for May. It deals with OOS/OOT and atypical results in endotoxin testing.


EMA/CHMP publishes new Q&A Document on Comparability Considerations for ATMPs

A document on the topic of comparability in the context of Changes and Variations at ATMP, published in December by the EMA, respectively the CAT, completes the series of guidelines and assistance around ATMP.


Guide on the Use of Type V Drug Master Files for Combination Products

In October 2019, the FDA issued guidelines in a draft document regarding the use of a Type V Drug Master File (DMF). In this document, information can be made available to the CDER (if it is in charge of the (project) approval procedure) concerning the medical device proportion of a combination product.


Clinical Trials Regulation Questions & Answers Version 2.2

The European Commission (EC) published an updated Version 2.2 of the Questions & Answers relating to the Clinical Trials Regulation.


Harmonisation of the pharmacopoeial Texts for use in the ICH Regions on Micro Enumeration finalized

Reaching step 5 of the harmonisation process, the European Medicines Agency (EMA) adopted the ICH guideline Q4B Annex 4A on evaluation and recommendation of pharmacopoeial texts for use in the ICH regions on micro enumeration.


Specified Microorganisms - Harmonisation of the pharmacopoeial Chapters completed

The International Council for Harmonistion (ICH) finalized their recommendation relating to the use of the pharmacopoeial texts on tests for specified microorganisms.


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