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How to demonstrate comparability for ATMPs?

  • 18 мая 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 апреля 2020
  • Annex 21, GMP, IMP, import, investigational medicinal product, medicinal products, QP, QP certification, QP confirmation,
On 20 March 2020, the European Commission (EC) released for 3 months consultation (till 20 June 2020) a draft version of Annex 21: Importation of medicinal products of the EU GMP Guide. The draft document is establishing a common understanding of the term importation which is defined as the action of physically bringing medicinal product,
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Medical Devices Regulation

  • 21 апреля 2020
  • Медицинские устройства, Регламент (ЕС) 2017/745,
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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First non-injectable treatment for severe hypoglycaemia!

  • 30 октября 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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“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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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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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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Клинические испытания лекарственных средств с участием детей – Добавление к ICH E11

  • 17 октября 2017
  • ICH E11, клинические испытания, клинические исследования, компьютерная симуляция, компьютерное моделирование, лекарственные формы для детей, педиатрическая популяция, разработка лекарственных препаратов, разработка лекарственных средств, экстраполяция,
On 6 October 2017, the European Medicines Agency (EMA) published revised version of ICH E11(R1) guideline on clinical investigation of medicinal products in the pediatric population in the form of an addendum. This document will become effective on 28 February 2018. Pediatric drug development has evolved since the original ICH E11 Guideline (2000), requiring consideration
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Пересмотренные руководящие принципы первых клинических исследований на людях – FIH CTs (Part II)

  • 30 июля 2017
  • 1 фаза, FIH, IMP, интегрированный протокол клинического исследования, исследуемый препарат, начальные клинические испытания, первые исследования на людях, первые клинические испытания на людях, снижение риска,
On 25 July 2017, the European Medicines Agency (EMA) published revised version of Guideline on strategies to identify and mitigate risks for first-in-human and early clinical trials with investigational medicinal products. This revised document will become effective on 1 February 2018. We have already informed on our website about a draft of the revised guideline
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