The European Medicines Agency (EMA) proposes a revision of the Guideline on quality, non-clinical and clinical aspects of medicinal products containing genetically modified cells and published an corresponding concept paper incuding the current scientific developments.
The US FDA published Advisory on Legal Restrictions on the Use of Mitochondrial Replacement Techniques to Introduce Donor Mitochondria into Reproductive Cells Intended for Transfer into a Human Recipient.
Once again, the FDA has issued a Warning Letter to an Indian pharmaceutical manufacturer. The state of the manufacturing equipment and the missing validation of a tableting process were the main points of criticism. Find out more about the Warning Letter due to equipment deficiencies.
The FDA issued a Warning Letter objecting to inadequate microbiological testing and product contamination with Burkholderia Cepacia and other microorganisms and following adverse events. Find out more abou the FDA Warning Letter.
The webinar "Audit Trail Review" took place in February 2017. Its aim was to address the main elements of data integrity and audit trail reviews. Participants have sent more than 50 questions regarding the webinar which the speaker, Dr Wolfgang Schumacher, has partly answered in writing. Learn more about the Webinar Audit Trail Review and about the corresponding questions asked.
The EU Commission published two new GMP documents in the Official Journal of the European Union. Learn more about the GMP Directive 2017/1572 for medicinal products for human use and the Delegated Regulation 2017/1569 on GMP for investigational medicinal products (IMPs) and requirements for inspections.
The European Medicines Agency, EMA, has updated its page on Mutual Recognition Agreements (MRA). Read more about the Questions and answers on impact of EU-US mutual recognition agreement on marketing authorization applications and relevant variations.
The EMA recently published a Questions and Answers document in relation to presentation of process information in the marketing authorization dossier and management of changes to an approved design space. Read more about the document on "Improving the understanding of NORs, PARs, DSp and normal variability of process parameters".
The recently published ICH question/answer document on starting materials specifies the regulations of the guideline ICH Q11. Read more about what is important in terms of the selection of starting materials and their justification and what data needs to be supplied in the marketing authorisation dossier.
In June 2017, the FDA opened a docket intended for public comments on the topic of continuous manufacturing. The FDA seems mainly interested in receiving comments on the C-SOPS document which was already published in 2016. This document contains recommendations of a group of U.S. university and industrial representatives regarding continuous production.
Both the ECA and the European QP Association are often contacted by people who would like to become a Qualified Person in a Member State of the European Union or outside the EU to release products for the EU market. Here is what you need to know about becoming a Qualified Person.
The International Council for Harmonisation (ICH) recently published its proposed E9 Addendum to define the appropriate estimand for a clinical trial. Read more about the draft E9(R1) Addendum: Statistical Principles for Clinical Trials.
The EMA published its new Guideline on Manufacture of the finished dosage form. The new EU guidance will help applicants in preparing marketing authorization dossiers and in what to include in Module 3 of their common technical document.
Recently, the FDA published a new Guidance for Industry draft document. It is intended to help medical gas manufacturers introduce and implement GMP regulations. Read more about GMP requirements for medical gases.
The FDA is proposing a more restrictive expiration dating for unit-dose repackaged solid oral dosage forms. Read more about FDA´s draft guidance Expiration Dating of Unit-Dose Repackaged Solid Oral Dosage Form Drug Products.