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

  • 2 November 2021
  • active substance, API, certificate, change, coronavirus, COVID-19, ECMP, EudraVigilance, expectations, flexibility, GDP, GMP, ICSR, import, IMs, inspection, MAH, manufacturing, pandemic, pharmacovigilance, PV, QP, QP certification, QPPV, regulation, regulatory, remote, SARS-Cov-2, SMs, variation,
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
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The use of monoclonal antibodies to treat COVID-19

  • 8 February 2021
  • ACTEMRA, application, AstraZeneca, AZD7442, bamlanivimab, benefits, casirivimab, Celltrion, CHMP, cilgavimab, CMA, conditional marketing authorisation, COVID-19, CT-P59, EC, EEA, Eli Lilly, EMA, etesevimab, EU, Evusheld, F. Hoffman-La Roche Ltd, FDA, GlaxoSmithKline, GSK4182136, imdevimab, mAb, monoclonal antibodies, regdanvimab, Regeneron Pharmaceuticals Inc., Regkirona, REGN-COV2, risks, RoActemra, Roche, rolling review, SARS-Cov-2, sotrovimab, tixagevimab, tocilizumab, Vir Biotechnology Inc., VIR-7831,
EMA’s human medicines committee (CHMP) is reviewing available data on the use of the monoclonal antibodies casirivimab, imdevimab, bamlanivimab and etesevimab to treat patients with COVID-19 who do not require oxygen supplementation and who are at high risk of progressing to severe COVID-19. The committee will carry out two separate reviews, one for the casirivimab/imdevimab
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How to demonstrate comparability for ATMPs?

  • 18 May 2020
  • advice, API, approach, ATIMP, ATMP, change, CHMP, clinical, comparability, data, development, drug product, drug substance, efficacy, EMA, exercise, final, finished, GMP, manufacturing, methodology, non-clinical, pivotal, process, product, profile, program, quality, RBA, risk-based, safety, scientific, site, stability, stage, statistical, studies, transfer,
  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
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Metformin diabetes medicines and N-nitrosodimethylamine (NDMA) – a probable human carcinogen

  • 7 December 2019
  • acceptable, active substance, AI, API, authority, cancer, carcinogen, CEP, daily, diabetes, drug, drug product, EDQM, EMA, EU, FDA, GMP, HCl, HSA, human, hydrochloride, ICH M7, impurity, intake, investigation, manufacturing process, market, medicinal product, medicines, metformin, N-nitrosodimethylamine, NDMA, nitrosamine, recall, root cause, Streuli Pharma AG, Swissmedic, type 2, withdrawal,
    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
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First non-injectable treatment for severe hypoglycaemia!

  • 30 October 2019
  • administration, Baqsimi, centralised procedure, CHMP, CP, demonstration, device, diabetes, dispenser, Eli Lilly Nederland B.V., EMA, EU, formulation, glucagon, glucose, hypoglycaemia, instructional, insulin, kit, leaflet, low blood sugar level, MA, MAH, marketing authorization, measures, medicinal product, minimization, nasal powder, non-injectable, novel, pharmaceutical, risk, severe, single-use, training, treatment, video,
On 17 October 2019, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation in the European Union for the medicinal product Baqsimi, intended for the treatment of severe hypoglycaemia. It is the first treatment for severe hypoglycaemia (low blood sugar levels) that can be
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Esketamine (Spravato) with the positive CHMP opinion for combination treatment in adults with treatment-resistant major depressive disorder

  • 23 October 2019
  • adult, antidepressant, CAP, centralised procedure, CHMP, combination, CP, depression, depressive, disorder, EMA, esketamine, EU, Janssen-Cilag International N.V., MA, MAH, major, marketing authorization, medicinal product, nasal spray solution, SNRI, Spravato, SSRI, TRD, treatment, treatment-resistant,
On 17 October 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 Spravato, intended for combination treatment in adults with treatment-resistant major depressive disorder. The applicant for this medicinal product is Janssen-Cilag International N.V. Product information (PI) on Spravato
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Nitrosamines in human medicines – consequences for MAHs

  • 7 October 2019
  • 4-(methyl)(nitroso)amino)butanoic acid, acceptable intake, active substance, AI, analysis, API, ASMF, authorities, cancer, candesartan, carcinogen, CEP, change, chemically synthesized, CHMP, competent, confirmatory, contamination, cross-contamination, detection, DIPNA, drug product, EIPNA, EMA, evaluation, finished product, formation, generics, GMP, HCl, human, hydrochloride, ICH M7, impurity, interim, irbesartan, limit, losartan, MA, MAH, manufacturer, manufacturing, manufacturing authorisation, marketing authorisation holder, medicinal product, medicines, method, MIA, mitigate, N nitrosodiethylamine, N-nitrosodiisopropylamine, N-nitrosodimethylamine, N-nitrosoethylisopropylamine, NDEA, NDMA, nitrosamine, NMBA, non-sartans, olmesartan, OTC, pioglitazone, process, public health, ranitidine, referral procedure, review, risk, sartans, specific ring structure, temporary, test, testing, tetrazole, valsartan, variation,
    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
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“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
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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
  • 4-(methyl)(nitroso)amino)butanoic acid, acceptable intake, active substance, AI, API, Article 31, benefit-risk balance, cancer, candesartan, carcinogen, CEP, cimetidine, detection, DIPNA, drug product, EC, EDQM, EIPNA, EMA, esomeprazole, European Commission, famotidine, FDA, finished product, HCl, heartburn, histamine receptors blocker, human, hydrochloride, ICH M7, impurity, irbesartan, lansoprazole, LC-MS, limit, losartan, MA, MAH, market, medicinal product, medicines, method, N nitrosodiethylamine, N-nitrosodiisopropylamine, N-nitrosodimethylamine, N-nitrosoethylisopropylamine, NDEA, NDMA, Nexium, nitrosamine, nizatidine, NMBA, olmesartan, omeprazole, OTC, Pepcid, Prevacid, Prilosec, ranitidine, recall, referral procedure, review, root cause, sartans, specific ring structure, stomach, Tagamet, tetrazole, ulcers, USA, valsartan, withdrawal,
    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
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