Guideline for Medicinal Products containing genetically modified Cells - EMA plans Revision

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.


Legal Restrictions on the Use of Mitochondrial Replacement Techniques to Introduce Donor Mitochondria into Reproductive Cells

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.


FDA Information about Human Cell and Tissue (HCT/P) related Inspections

The US Food & Drug Administration (FDA) published an overview about HCT/P inspections in the last five fiscal years.


EMA - New guide for healthcare professionals on biosimilar medicines

The European Medicines Agency (EMA), the European Commission and experts from the Member States issued a new Guide for Healthcare Professionals on Biosimilars.


Warning Letter to Indian API Manufacturer: Equipment Deficiencies

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.


FDA aligns Inspection and Regulatory Affairs Systems

The US Food & Drug Administration (FDA) plans to better coordinate regulatory affairs and field inspection activities to strengthen inspection and oversight of drug manufacturing worldwide.


FDA Warning Letter relating to the Use of an alternative microbiological Method

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.


Important Questions and Answers concerning the Audit Trail Review

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.


New EU GMP Guideline for IMPs

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.


EMA updates Website on Mutual Recognition Agreements

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.


EMA´s Questions and Answers relating to Flexibility in Manufacturing Conditions

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".


API starting materials - New Q&A document for ICH Q11

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.


EMA Non-Compliance Report for Brazilian Manufacturer of sterile Products

During an inspection, the Italian regulatory agency found major deficiencies at the site of a Brazilian manufacturer of antibiotics. Read more about the EMA's Non-Compliance Report.


FDA opens Docket on Continuous Manufacturing

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.


How to become a QP in Europe

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.


New ICH E9 Addendum reaches Step 2b of the ICH Process

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.


QbD: New EMA Guideline on Manufacture of the finished Dosage Form

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.


Safety by Design: EMA Reflection Paper on Development of Medicines for Use in the older Population

The EMA recently published a draft Reflection Paper on the pharmaceutical development of medicines for use in the older population.


FDA publishes Draft Guidance for Medical Gases

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.


Test for Subvisible Particles: ICH Harmonisation Completed

With Step 5, harmonisation regarding the use of pharmacopoeial methods for test for subvisible particles in the ICH regions has been completed. Read more about Tests for Subvisible Particles.


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