Regulatory requirements for medicinal products for human use in the context of the COVID-19 pandemic

2 November 2021
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The European Commission, EMA and the European medicines regulatory network have developed a question-and-answer (Q&A) document to provide guidance to stakeholders on adaptations to the regulatory framework to address challenges arising from the COVID-19 pandemic, with a particular focus on crucial medicines for use in COVID-19 patients. The document explains some regulatory flexibilities that can

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
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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

Metformin diabetes medicines and N-nitrosodimethylamine (NDMA) – a probable human carcinogen

7 December 2019
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NEW! URGENT! Update [19/10/2020] EMA and EU national competent authorities will be contacting all marketing authorisation holders of metformin-containing medicines, used for the treatment of diabetes, to request they implement testing of the medicines for the presence of nitrosamines before they are released onto the market. This is a precautionary step to ensure

Nitrosamines in human medicines – consequences for MAHs

7 October 2019
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EMA’s human medicines committee (CHMP) is requesting as a matter of precaution that marketing authorisation holders (MAHs) for human medicines containing chemically synthesised active substances review their medicines for the possible presence of nitrosamines and test all products at risk. If nitrosamines are detected in any of their medicines, marketing authorisation holders must

“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
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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

Review of widely used ranitidine medicines to treat conditions such as heartburn and stomach ulcers due to detection of impurity, N-nitrosodimethylamine (NDMA), a probable human carcinogen!

23 September 2019
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EMA is to start a review of ranitidine medicines after tests showed that some of these products contained an impurity called N-nitrosodimethylamine (NDMA) at levels which raise concerns according to the principles of the ICH M7 guideline. The results on a limited sample of products showed that for the majority of both ranitidine

EU and US reach a milestone in mutual recognition of inspections of medicines manufacturers – implications for QPs

29 August 2019
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With the recognition by the US Food and Drug Administration (FDA) of Slovakia, the last outstanding EU Member State, the European Union and the United States have now fully implemented the Mutual Recognition Agreement (MRA) for inspections of manufacturing sites for certain human medicines in their respective territories. It means that the US Food and

The exemption from EU batch re-testing for imported ATMPs

27 August 2019
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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

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

27 June 2019
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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)