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Пересмотр Руководства по GMP EC – Приложение 2

  • 27 августа 2018
  • active substance, Annex 2, API, biological, EC, GMP, manufacture, medicinal product, revision,
The revised Annex 2: Manufacture of Biological active substances and Medicinal Products for Human Use of the EU GMP Guide came into operation on 26 June 2018. Annex 2 has been revised as a consequence of the adoption of the Guidelines on Good Manufacturing Practice specific to Advanced Therapy Medicinal Products. The previous version of
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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 II)

  • 20 августа 2018
  • active substance, API, carcinogen, CEP, distribution, EDQM, EMA, human, hypertension, impurity, manufacturer, manufacturing, medicinal product, medicines, N-nitrosodimethylamine, NDMA, recall, review, stopping, suspension, valsartan, Zhejiang Tianyu,
The company Zhejiang Tianyu is no longer authorised to manufacture the valsartan active substance for EU medicines following the suspension of its CEP – a certificate verifying that the quality of its valsartan meets European requirements. The suspension of the certificate by the European Directorate for the Quality of Medicines and Healthcare (EDQM) comes after
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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 I)

  • 16 августа 2018
  • active substance, animal test, API, cancer, carcinogen, CEP, change, EDQM, EMA, FDA, final product, formation, health effect, Hetero Labs Limited, human, hypertension, impurity, manufacturer, manufacturing, medicinal product, medicines, N-nitrosodimethylamine, NDMA, OMCL, patient, process, recall, review, risk, safety profile, side product, suspension, valsartan, Zhejiang Huahai Pharmaceuticals, Zhejiang Tianyu,
The European Medicines Agency (EMA) is reviewing medicines containing the active substance valsartan. Valsartan medicines are used to treat patients with high blood pressure in order to reduce complications such as heart attack and stroke. It is also used in patients who have had heart failure or a recent heart attack. It should be noted
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Pharmaceutical industry Brexit preparedness and its legal consequences for MAH

  • 13 ноября 2017
  • API, CMDh, CMDv, CP, DCP, EC, EMA, GMP, MA, MAH, MRP, QPPV, RMS, активный фармацевтический ингредиент, АФИ, Брексит, владелец регистрационного удостоверения лекарственного препарата, выпуск серии, выход Великобритании из ЕС, готовая продукция, готовый препарат, действующее вещество, держатель регистрационного удостоверения лекарственного препарата, ЕАЛС, Европейская комиссия, Европейское агентство лекарственных средств, ЕК, изменение в регистрационном удостоверении лекарственного препарата, импорт, лекарственное средство, лекарственный препарат, место, НПП, передача регистрационного удостоверения на лекарственный препарат, правовые последствия, производство, регистрационное удостоверение лекарственного препарата, уведомление,
On 2 May 2017, the European Commission and EMA published a Notice to marketing authorisation holders of centrally authorised medicinal products for human and veterinary use, stating: “The United Kingdom submitted on 29 March 2017 the notification of its intention to withdraw from the Union pursuant to Article 50 of the Treaty on European Union.
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(Q)SAR models – important tool of risk assessment to support practical implementation of ICH M7 guideline

  • 29 сентября 2017
  • (Q)SAR, GTIs, ICH M7, генотоксические примеси, квалификация примесей, КССА, мутагенные примеси, принципы валидации, прогнозирование мутагенности, тесты на мутагенность,
A general concept of qualification of impurities (or degradation products) is described in the ICH Q3A/B guidelines, whereby qualification is defined as the process of acquiring and evaluating data that establishes the biological safety of an individual impurity (or degradation product) or a given impurity (or degradation) profile at the level(s) specified. Therefore to limit
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EMA published Guideline on process validation (PV) for the manufacture of biotechnology-derived active substances and data to be provided in the regulatory submission

  • 18 июля 2016
On 29 April 2016, EMA published a new document entitled Guideline on process validation for the manufacture of biotechnology-derived active substances and data to be provided in the regulatory submission. The new guideline will become effective on 1 November 2016. It should be noted that the need to develop guidance on process validation of biotechnology
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EMA published a Draft guideline on the sterilisation of the medicinal product, active substance, excipient and primary container (Part I)

  • 29 июня 2016
  • API, GMP, SAL,
On 13 April 2016, EMA released for 6 months public consultation the Draft guideline on the sterilisation of the medicinal product, active substance, excipient and primary container. A new guidance is developed as a separate guidance document and will replace Decision trees for the selection of sterilisation methods (CPMP/QWP/054/98) and Decision trees for the selection
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Определение новой активной субстанции (NAS, New Active Substance) которое касается химических веществ

  • 1 марта 2016
On 19 January 2016, the European Medicines Agency published a new document entitled Reflection paper on the chemical structure and properties criteria to be considered for the evaluation of new active substance (NAS) status of chemical substances. This document is intended to reflect the current experience concerning the definition of a New Active Substance (NAS) in
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Исходное сырьё для производства действующего вещества (АФИ) – важность выбора

  • 4 декабря 2014
  • API, GMP, ICH Q11, MCB, WCB, активный фармацевтический ингредиент, АФИ, банки клеток, Главный банк клеток, действующее вещество, исходное сырье, исходное сырье для производства действующего вещества, клеточные субстраты, НПП, Рабочий банк клеток,
According to the Part II: Basic Requirements for Active Substances used as Starting Materials of the EU GMP Guide, the manufacturer should designate and document the rationale for the point at which production of the active substance begins. For synthetic processes, production of the active substance begins at the point at which „Active Substance Starting
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Аудиты производителей и дистрибьюторов активных субстанций – правовая основа

  • 29 сентября 2014
According to an Article 46(f) of Directive 2001/83/EC as amended for medicinal products for human use, the holder of a manufacturing authorization shall at least be obliged: “to comply with the principles and guidelines of good manufacturing practice for medicinal products and to use as starting materials only active substances, which have been manufactured in accordance with
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