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

29 августа 2019
agreement, batch, consequence, EC, EU, FDA, GMP, human, implication, inspection, manufacturer, manufacturing, medicines, milestone, MRA, Mutual Recognition Agreement, phase, QP, site, testing, transition, US, USA, waiver,

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

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The exemption from EU batch re-testing for imported ATMPs

27 августа 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

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

8 июля 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

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

27 июня 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)

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Omega-3 fatty acid medicines are not effective in preventing further heart problems after a heart attack!

25 июня 2019
benefit, benefit-risk balance, blood vessels, clinical, CT, DHA, effective, EPA, fish oils, heart attack, heart problems, hypertriglyceridaemia, indication, MA, marketing authorisation, medicinal product, medicines, MI, myocardial infarction, not, Omacor, Omega-3 fatty acid, open-label study, oral use, PI, preventing, product information, re-examination, reference, scientific conclusions, secondary prevention, supplementation, treatment, trials, variation,

On 29 March 2019 EMA confirmed that omega-3 fatty acid medicines containing a combination of an ethyl ester of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) – EPA and DHA are commonly found in fish oils – at a dose of 1 g per day are not effective in preventing further problems with the heart

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Review of common medicines used to treat hypertension – valsartan – due to detection of impurity, N-nitrosodimethylamine (NDMA), a probable human carcinogen! (Part VIII)

29 мая 2019
4-(methyl)(nitroso)amino)butanoic acid, active substance, angiotensin-II-receptor antagonists, angiotensin-II-receptor blockers, API, ARBs, Article 31, azilsartan, cancer, candesartan, carcinogen, CEP, conditions to MA, diabetes, DIPNA, drug product, EC, EDQM, EIPNA, EMA, eprosartan, European Commission, Hetero Labs, human, hypertension, impurity, interim, investigation, irbesartan, legally binding decision, limit, losartan, MA, MAH, manufacturer, manufacturing, manufacturing process, manufacturing site, marketing authorisation holder, medicinal product, medicines, N-nitrosodiethylamine, N-nitrosodiisopropylamine, N-nitrosodimethylamine, N-nitrosoethylisopropylamine, NDEA, NDMA, nitrosamine, NMBA, olmesartan, pioglitazone, review, root cause, sartans, scientific conclusion, specific ring structure, suspension, telmisartan, temporary, tetrazole, valsartan, Zhejiang Huahai Pharmaceuticals,

IMPORTANT! Update [28/10/2020] Having considered the knowledge acquired on the presence of nitrosamines in medicinal products since the sartans referral and taking into account the data assessed within the review under Article 5(3), in particular related to the root causes where it became clear that the root causes can be numerous, concomitant, at

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Brexit and EU rules for medicinal products for human use and veterinary medicinal products

7 марта 2019
API, CP, EC, EMA, GMP, MA, MAH, QPPV, RMS, активный фармацевтический ингредиент, АФИ, Брексит, владелец регистрационного удостоверения лекарственного препарата, выпуск серии, выход Великобритании из ЕС, готовая продукция, готовый препарат, действующее вещество, держатель регистрационного удостоверения лекарственного препарата, ЕАЛС, Европейская комиссия, Европейское агентство лекарственных средств, ЕК, изменение в регистрационном удостоверении лекарственного препарата, импорт, лекарственное средство, лекарственный препарат, место, НПП, передача регистрационного удостоверения на лекарственный препарат, переходный период, правовые последствия, производство, регистрационное удостоверение лекарственного препарата, уведомление,

DO NOT RELY ON THE TRANSITION PERIOD! The European Commission have published revised versions of Notice to stakeholders and Questions and Answers (Q&As) documents in 22 official EU languages. DO NOT RELY ON THE TRANSITION PERIOD! DOCUMENTS: DO NOT RELY ON THE TRANSITION PERIOD! Sources: EC, EMA

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Brexit and EU rules in the field of clinical trials (CTs)

5 марта 2019
Brexit, clinical trials, CT, database, EC, EudraCT, IMP, import, investigational medicinal product, legal consequences, notice, sponsor, UK's withdrawal,

In view of the considerable uncertainties, in particular concerning the content of a possible withdrawal agreement, sponsors (both academic researchers and pharmaceutical companies) conducting or planning to conduct clinical trials, as well as investigators and other persons involved in the preparation and conduct of clinical trials in the EU are reminded of legal repercussions, which

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Brexit and EU rules for batch testing of medicinal products

27 февраля 2019
batch release, batch testing, Brexit, CMDh, CMDv, CP, DCP, EC, EMA, exemption, finished product, import, MA, MAH, marketing authorisation, marketing authorisation holder, medicinal products, MRP, notice, template for request, transfer, UK's withdrawal,

According to Article 51(1)(b) of Directive 2001/83/EC and Article 55(1)(b) of Directive 2001/82/EC, medicinal products imported into the EU have to undergo quality control testing (‘batch testing’) in the EU/EEA. In these cases, Article 20(b) of Directive 2001/83/EC and 24(b) of Directive 2001/82/EC provide that competent authorities may allow importers of medicinal products coming from

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Review of common medicines used to treat hypertension – valsartan – due to detection of impurity, N-nitrosodimethylamine (NDMA), a probable human carcinogen! (Part VII)

22 ноября 2018
active substance, API, cancer, candesartan, carcinogen, CEP, drug product, EDQM, EMA, FDA, GC-MS/MS, GMP, human, hypertension, impurity, inspection, intermediate, irbesartan, losartan, MAH, manufacturer, manufacturing, manufacturing site, marketing authorisation holders, medicinal product, medicines, method, Mylan Laboratories Limited, N-nitrosodiethylamine, N-nitrosodimethylamine, NDEA, NDMA, nitrosamine, non-compliance, olmesartan, recall, review, sartans, specific ring structure, statement, suspension, test, tetrazole, valsartan, Zhejiang Huahai Pharmaceuticals,

EMA Authorities in the EU are taking action after an impurity, N-nitrosodiethylamine (NDEA), was found in some batches of valsartan made by Mylan Laboratories Limited in Hyderabad, India. EDQM Following new information recently received by EDQM about the detection of low levels of N-nitrosodiethylamine (NDEA) in Valsartan manufactured by Mylan Laboratories Ltd, the

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