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 first cannabidiol containing medicinal product with a positive opinion in the EU centralised procedure!

22 августа 2019
cannabidiol, cannabis, CBD, centralised procedure, CHMP, clobazam, CP, Dravet syndrome, DS, EMA, Epidyolex, epilepsy, EU, GW Pharma (International) B.V., Lennox-Gastaut syndrome, LGS, MA, MAH, marketing authorization, medicinal product, oral solution, orphan designation, orphan medicine, seizures,

On 25 July 2019, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Epidyolex, intended for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS) or Dravet syndrome (DS), two forms of epilepsy. The applicant for this medicinal product is

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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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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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Withdrawal of marketing authorisations for fenspiride medicines!

24 мая 2019
benefit-risk balance, CMDh, cough, EMA, EU, fenspiride, heart rhythm problems, MA, medicinal product, medicines, negative, PRAC, QT prolongation, supply, suspended, symptomatic treatment, syrup, tablet, torsades de pointes, withdrawal of MA, withdrawal of marketing authorisation, дополнительные исследования, удлинение интервалов QT на электрокардиограмме, фенспирид,

EMA’s safety committee (PRAC) has recommended that the marketing authorisations for fenspiride medicines be revoked, so the medicines can no longer be marketed in the EU. This follows a review that has confirmed that these cough medicines could cause heart rhythm problems. Given the authorised uses of fenspiride for symptomatic treatment only and the seriousness

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

16 октября 2018
active substance, API, Aurobindo Pharma, cancer, candesartan, carcinogen, CEP, corrective measures, drug product, EDQM, EMA, FDA, GMP, headspace GC/MS, human, hypertension, impurity, inspection, irbesartan, losartan, MAH, manufacturer, manufacturing, manufacturing site, marketing authorisation holders, medicinal product, medicines, method, monitor, N-nitrosodimethylamine, NDEA, NDMA, nitrosamine, non-compliance, N‑nitrosodiethylamine, olmesartan, OMCL, recall, review, sartans, specific ring structure, statement, suspension, test, tetrazole, UHPLC-APCI-MS/MS, valsartan, Zhejiang Huahai Pharmaceuticals,

EMA EU authorities are placing the Chinese company Zheijiang Huahai under increased supervision following European and US inspections which revealed weaknesses in quality management at the company’s Chuannan site in Linhai, China and will supervise the manufacture of other active substances produced by this company more closely. Low levels of NDEA have now also

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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 V)

3 октября 2018
active substance, APCI-UHPLC-MS/MS, API, cancer, candesartan, carcinogen, CEP, drug product, EDQM, EMA, FDA, formation, GMP, headspace GC/MS, Hetero Labs Limited, HPLC-UV, human, hypertension, import alert, impurity, inspection, intermediate, irbesartan, losartan, MAH, manufacturer, manufacturing, manufacturing site, marketing authorisation holders, medicinal product, medicines, method, N-nitrosodimethylamine, NDEA, NDMA, nitrosamine, non-compliance, N‑nitrosodiethylamine, olmesartan, OMCL, patient, process, recall, review, risk, sartans, specific ring structure, statement, suspension, test, tetrazole, valsartan, Zhejiang Huahai Pharmaceuticals,

EMA The European Medicines Agency (EMA) is expanding its review of impurities in valsartan following the detection of very low levels of N-nitrosodiethylamine (NDEA) in another active substance, losartan, made by Hetero Labs in India. As a result of the detection of this impurity by German authorities, the review will now include medicines containing

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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 IV)

19 сентября 2018
active substance, API, cancer, carcinogen, CEP, EDQM, EMA, headspace GC/MS, human, hypertension, impurity, inspection, investigation, manufacturer, manufacturing, manufacturing site, medicinal product, medicines, method, N-nitrosodimethylamine, NDEA, NDMA, nitrosamine, N‑nitrosodiethylamine, OMCL, patient, process, recall, review, risk, sartans, test, valsartan, Zhejiang Huahai Pharmaceuticals, Zhejiang Tianyu Pharmaceutical Co. Ltd.,

EMA The European Medicines Agency (EMA) has updated its calculation of the risk from valsartan medicines containing N‑nitrosodimethylamine (NDMA), taking into account results from latest tests on the active substance from Zhejiang Huahai. In addition to NDMA, EMA is assessing the impact of a related substance, N‑nitrosodiethylamine (NDEA), which has been detected in valsartan

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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 III)

29 августа 2018
active substance, API, cancer, carcinogen, CEP, detection, EDQM, FDA, final product, headspace GC/MS, Hetero Labs Limited, holder, human, hypertension, impurity, investigation, manufacturer, manufacturing, medicinal product, medicines, method, N-nitrosodimethylamine, NDMA, nitrosamine, OMCL, patient, process, quantification, recall, review, risk, suspension, Torrent Pharmaceuticals Limited, valsartan, Zhejiang Changming Pharmaceutical Co. Ltd., Zhejiang Huahai Pharmaceuticals, Zhejiang Tianyu Pharmaceutical Co. Ltd.,

EDQM The EDQM is continuing the investigations and actions which started in July 2018 to address the issue related to the detection of a nitrosamine (N-nitrosodimethylamine (NDMA)) in a source of active substance valsartan. Following the suspension of the CEP on valsartan held by Zhejiang Huahai Pharmaceutical Co. Ltd, the EDQM has also

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