How to demonstrate comparability for ATMPs?

18 May 2020
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CHMP scientific advice questions are often related to the suitability of comparability proposals following changes to ATMP manufacturing processes or due to introduction of additional manufacturing sites. Manufacturing process changes may encompass improvements/change in Such changes are frequent, especially in the early stages of development of ATMPs. A suitable comparability program is required to

EU GMP Guide – Annex 21: Importation of medicinal products

23 April 2020
Annex 21, GMP, IMP, import, investigational medicinal product, medicinal product, QP, QP certification, QP confirmation,

Update [21/03/2022] On 21 February 2022, the European Commission (EC) has published a final version of the new Annex 21: Importation of medicinal products of the EU GMP Guide. This new annex comes into operation on 21 August 2022. Update Due to the challenges posed by COVID-19, the timeline for the targeted consultation has

“Guideline on the sterilisation of the medicinal product, active substance, excipient and primary container” published by EMA will come into force on 1 October 2019 (Part II)

30 September 2019
active substance, API, aseptic processing, ATMP, cell based medicinal products, container, decision tree, documentation, dossier, EMA, excipients, filtration, finished dosage form, finished product, GMP, medicinal product, part, Ph. Eur., post-aseptic processing terminal heat treatment, primary, quality, SAL, sterilisation, sterilisation assurance level, sterility, terminal sterilisation,

On 8 March 2019, the European Medicines Agency (EMA) published final version of Guideline on the sterilisation of the medicinal product, active substance, excipient and primary container. This guideline will come into force on 1 October 2019. Guidance is also provided on the documentation expected for sterile finished products, sterile active

The exemption from EU batch re-testing for imported ATMPs

27 August 2019
11.17, applicant, ATMP, authorised, autologous, batch, control, country, EEA, EMA, EU, exemption, GMP, guidelines, import, MA, MAH, paragraph, patient, product, Q&A, QP, quality, re-testing, section, specific, third,

On 21 August 2019 EMA has published document entitled Questions and answers on the exemption from batch controls carried out on ATMPs imported into the European Union from a third country. The exemption from re-testing batches upon import into the EU for authorised ATMPs may only be granted where the conditions laid down in paragraph

“Guideline on quality, non-clinical and clinical requirements for investigational advanced therapy medicinal products (ATIMPs) in clinical trials” in the consultation phase

8 July 2019
analysis, animal, ATIMP, ATMP, cell, clinical, confirmatory, CT, CTD, development, dossier, early, editing, efficacy, EMA, exploratory, FIH, FIM, gene, genetic, genome, guideline, healthy, IMP, IMPD, late, MA, manipulation, manufacturing, model, modification, Module 3, multidisciplinary, non-cellular, non-clinical, patient, phase, population, protocol, QC, quality, quality control, requirements, risk, safety, study, subject, trial, type, vector, volunteer,

On 21 February 2019, the European Medicines Agency (EMA) has published the draft Guideline on quality, non-clinical and clinical requirements for investigational advanced therapy medicinal products in clinical trials. The public consultation phase will last until 1 August 2019. The main objective of this guideline is to avoid discrepancies across the EU regarding the requirements

Use of OOS batches of authorised cell/tissue-based ATMPs – Section 11.5 of the Guidelines on GMP for ATMPs

27 June 2019
ATMP, authorized, batches, CAT, cell/tissue-based, EMA, GMP, guidelines, implementation, MA, OOS, patient, provision, Q&A, section 11.5, use,

On 25 June 2019 EMA has published document entitled Questions and answers on the use of out-of-specification batches of authorised cell/tissue-based advanced therapy medicinal products prepared by EMA’s CAT, together with the GMDP Inspectors Working Group and the Blood Products Working Party. Source: EMA Related entries: GMP for Advanced Therapy Medicinal Products (ATMPs)

GMP for Advanced Therapy Medicinal Products (ATMPs) (Part II) and hospital exemption (HE)

14 February 2018
advanced therapy medicinal product, aseptic manufacturing, ATMP, biosafety, clinical trials authorisation, CTA, data integrity, decentralized manufacturing, GMO, GMP, HE, hospital exemption, IMP, investigational medicinal product, MAH, manufacturer, manufacturing, manufacturing platform, marketing authorisation, marketing authorisation holder, operating theatre, process validation, risk assessment, sponsor, unmet medical needs,

On 22 November 2017, the European Commission (EC) has adopted and published Guidelines on Good Manufacturing Practice specific to Advanced Therapy Medicinal Products, one of the initiatives of the Action Plan for ATMPs launched in October 2017 to foster the development of ATMPs. Advanced Therapy Medicinal Products (ATMPs) manufacturers should comply with these Guidelines

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

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