Withdrawal of marketing authorisations for fenspiride medicines!

24 May 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,

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

Medicinal products

22 May 2019
EU, FDA, FDA approved drug products, medicinal products, Poland, register of medicinal products, Russia, union register of medicinal products,

REGISTERS OF MEDICINAL PRODUCTS MEDICINAL PRODUCTS A Azilsartan medoxomil B Bamlanivimab Bamlanivimab/Etesevimab C Candesartan cilexetil Cannabidiol Casirivimab/Imdevimab Chloroquine Cimetidine Clobazam E Eprosartan mesylate Esketamine Esomeprazole F Famotidine Fenspiride hydrochloride G Glucagon H Hydroxychloroquine I Irbesartan L Lansoprazole Losartan potassium M Metformin hydrochloride N Nizatidine O Olmesartan medoxomil Omega-3 fatty acid Omeprazole P Pioglitazone

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

7 March 2019
API, batch release, Brexit, CP, EC, EMA, finished product, GMP, impact, import, legal consequences, MA, MAH, manufacture, marketing authorisation, marketing authorisation holder, medicinal products, notice, QPPV, ratification, RMS, site, transfer, transition period, UK's withdrawal, variation, Withdrawal Agreement,

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

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

5 March 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

Brexit and EU rules for batch testing of medicinal products

27 February 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

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

22 November 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

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

16 October 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

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

3 October 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

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

19 September 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

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

29 August 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