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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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Vaccines against COVID-19

  • 10 December 2020
  • application, AstraZeneca, benefits, BioNTech, BNT162b2, ChAdOx1-SARS-CoV-2, CHMP, CMA, conditional marketing authorisation, COVID-19, COVID-19 Janssen, COVID-19 Vaccine (inactivated adjuvanted), COVID-19 Vaccine Janssen, CVST, DIC, EC, EEA, EMA, EU, FDA, Gam-COVID-Vac, Gamaleya National Centre of Epidemiology and Microbiology, Janssen-Cilag International N.V., Jcovden, MHRA, Moderna Biotech Spain S.L., mRNA, mRNA-1273, Novavax CZ a.s., Nuvaxovid, Oxford University, Pfizer, R-Pharm Germany GmbH, risks, rolling review, Russia, Sanofi Pasteur, SARS-Cov-2, Spikevax, Sputnik V, vaccine, Valneva, Vaxzevria, VidPrevtyn Beta,
Comirnaty (BNT162b2) (BioNTech and Pfizer) Spikevax (mRNA-1273) (Moderna Biotech Spain, S.L.) Vaxzevria (AstraZeneca/Oxford University) Jcovden (COVID-19 Vaccine Janssen) (Janssen-Cilag International N.V.) Nuvaxovid (Novavax CZ, a.s.) COVID-19 Vaccine (inactivated, adjuvanted) (Valneva) VidPrevtyn Beta (Sanofi Pasteur) Sputnik V (Gam-COVID-Vac) (Gamaleya National Centre of Epidemiology and Microbiology, Russia)     EXTENSION OF INDICATION Update [25/11/2021] EMA’s human medicines
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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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EU GMP Guide – Annex 21: Importation of medicinal products

  • 23 April 2020
  • Annex 21, GMP, IMP, import, investigational medicinal product, medicinal product, QP, QP certification, QP confirmation,
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
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Medical Devices Regulation

  • 21 April 2020
  • 2017/745, medical devices, regulation,
On 3 April 2020, the European Commission has adopted a proposal, to postpone by one year the date of application of the Medical Devices Regulation to allow Member States, health institutions and economic operators to prioritise the fight against the coronavirus pandemic. This proposal therefore postpones, for exceptional reasons in the current context, the application
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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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