Is the risk of GMP dis-harmonisation in the field of ATMPs (Advanced Therapy Medicinal Products) real?

12 May 2017
advanced therapy medicinal product, ATMP, GMP, harmonisation, IMP, investigational medicinal product, PIC/S,

The PIC/S Committee, which comprises representatives of PIC/S’ 49 Participating Authorities as well as representatives from Partner Organisations such as EMA, EDQM and WHO, expressed its unanimous concern at the European Commission’s proposed stand-alone Advanced Therapy Medicinal Products (ATMP) GMP Guidelines, which will not only lower GMP standards for ATMP at the risk of patients

First-in-human Clinical Trials – FIH CTs (Part I)

12 April 2017
3Rs, early clinical trials, FIH, first-in-human, IMP, integrated protocols, investigational medicinal product, phase I, reduction, refinement, replacement, risk mitigation,

Clinical trials are essential for the development of medicines and without them patients cannot gain access to new potentially life-saving medicines. EU and international guidelines are in place to ensure that first-in-human clinical trials are conducted as safely as possible. EMA’s existing guideline, released in 2007, provides advice on first-in-human clinical trials, in particular on

GMP and MAHs

13 October 2016
2019/6, EU, GMP, MAH, marketing authorisation holder, regulation,

Update [18/11/2021] On 29 July 2021, the European Medicines Agency (EMA) published final version of Reflection paper on Good Manufacturing Practice and Marketing Authorisation Holders. This Reflection Paper is focussed on the GMP-related responsibilities that apply to Marketing Authorisation Holder (MAH) companies and it seeks to provide clarity as to what the various responsibilities are

FDA has published “Quality Metrics Technical Conformance Guide”

30 September 2016

Recently, FDA has published a new technical specifications document entitled Quality Metrics Technical Conformance Guide. This Guide supplements and serves as the technical reference for implementation of the draft FDA guidance for industry on Request for Quality Metrics and additionally provides recommendations about submission of information that will support the FDA’s calculation of quality metrics.

GMP for ATMPs (Advanced Therapy Medicinal Products) (Part I)

15 September 2016
advanced therapy medicinal product, aseptic manufacturing, ATMP, clinical trials authorisation, CTA, data integrity, GMO, GMP, IMP, investigational medicinal product, MAH, manufacturer, manufacturing, marketing authorisation, marketing authorisation holder, process validation, risk assessment, sponsor,

On 28 June 2016, the European Commission (EC) released for 3 months consultation (till 26 September 2016) the draft Guidelines on Good Manufacturing Practice for Advanced Therapy Medicinal Products. Article 5 of Regulation No 1394/2007 of the European Parliament and of the Council on advanced therapy medicinal products and amending Directive 2001/83/EC states: The Commission

EMA published Guideline on process validation (PV) for the manufacture of biotechnology-derived active substances and data to be provided in the regulatory submission

18 July 2016

On 29 April 2016, EMA published a new document entitled Guideline on process validation for the manufacture of biotechnology-derived active substances and data to be provided in the regulatory submission. The new guideline will become effective on 1 November 2016. It should be noted that the need to develop guidance on process validation of biotechnology

EMA published a Draft guideline on the sterilisation of the medicinal product, active substance, excipient and primary container (Part I)

29 June 2016
Annex 1, API, aseptic processing, excipients, filtration, finished dosage form, GMP, medicinal product, primary container, SAL, sterilisation, sterilisation assurance level, sterility, terminal sterilisation,

On 13 April 2016, EMA released for 6 months public consultation the Draft guideline on the sterilisation of the medicinal product, active substance, excipient and primary container. A new guidance is developed as a separate guidance document and will replace Decision trees for the selection of sterilisation methods (CPMP/QWP/054/98) and Decision trees for the selection

Definition of a New Active Substance (NAS) for chemical substances

1 March 2016

On 19 January 2016, the European Medicines Agency published a new document entitled Reflection paper on the chemical structure and properties criteria to be considered for the evaluation of new active substance (NAS) status of chemical substances. This document is intended to reflect the current experience concerning the definition of a New Active Substance (NAS)

Revision of the EU GMP Guide – Annex 16

18 October 2015

On 12 October 2015, the European Commission published revised version of Annex 16: Certification by a Qualified Person and Batch Release of the EU GMP Guide. The new annex will become effective on 15 April 2016. General principles Revised version of the annex states that: The ultimate responsibility for the performance of a medicinal product over its

Revision of the EU GMP Guide – Annex 17 (Part I)

14 October 2015
Annex 17, GMP, parametric release, PAT, pharmaceutical development, QbD, QRM, RTRT,

On 15 September 2015, the European Commission released for public consultation (until 11 December 2015) a draft revised version of Annex 17: Real Time Release Testing of the EU GMP Guide. Comparing to current version of this annex, an application of the concept, which under specific circumstances, and where authorised, allows batch release based on information