NOTICIAS

O sector não pára e nós também não!

O sector não pára e nós também não!

Estamos de volta ao trabalho após o encerramento causado pela pandemia COVID-19 Estamos a trabalhar para lhe voltar a oferecer as nossas iniciativas de formação, em condições otimas de segurança, eficácia e conforto.  Nos próximos dias apresentaremos as datas do...

What is the state of play of the implementation of EUDAMED?

What is the state of play of the implementation of EUDAMED?

Currently, the EC database on medical devices, Eudamed2, is a secure web-based portal. It is a central repository for information on market surveillance exchanged between national competent authorities and the Commission. Its use is restricted to national competent...

EMA preparing big data Q&A guidance

EMA preparing big data Q&A guidance

EMA is preparing a question-and-answer guidance document on the impact of EU data protection legislation on the secondary use of health data in support of the development, evaluation and supervision of medicines. The aim is to help medicine developers, data providers...

Trade in Counterfeit Pharmaceutical Products

Trade in Counterfeit Pharmaceutical Products

This report, one in a series of studies by the OECD and the European Union Intellectual Property Office (EUIPO), is designed to enhance understanding of the issues and challenges facing governments, businesses and society posed by the trade in fake pharmaceutical...

Cambridge University :The Future of Medicine

Cambridge University :The Future of Medicine

Nanobots that patrol our bodies, killer immune cells hunting and destroying cancer cells, biological scissors that cut out defective genes: these are just some of the technologies that Cambridge University researchers are developing and which are set to revolutionise...

Union procedure on the follow-up of pharmacovigilance inspections

Union procedure on the follow-up of pharmacovigilance inspections

Date for coming into effect 01 May 2020 This procedure defines the steps in the follow-up of pharmacovigilance inspections and the responsibilities of the parties involved. This includes the process for requesting a CAPA plan in writing from the MAH, CAPA plan review...

Personalized Medical Devices – Regulatory Pathways

Personalized Medical Devices – Regulatory Pathways

The purpose of this IMDRF guidance is to recommend a harmonized approach for the application of existing regulatory pathways to medical devices that are intended for a particular individual, and to identify special considerations for the regulation of each identified...

Nova data regulamentação MDR: 26 maio 2021

Nova data regulamentação MDR: 26 maio 2021

O Regulamento dos Dispositivos Médicos 2017/745 (MDR), entrará oficialmente em vigor em 2021, o dia 26 de maio. NEWS FROM EP: The European Parliament has approved the amending Regulation (EU) 2017/745 on medical devices, as regards the dates of application of certain...

MDR postponed to may 2021

MDR postponed to may 2021

NEWS FROM EP: The European Parliament has approved the amending Regulation (EU) 2017/745 on medical devices, as regards the dates of application of certain of its provisions. MDR postponed to may 2021.   Parliament decides to postpone new requirements for medical...

European Commission Proposes to Delay MDR by a Year Due to COVID-19

European Commission Proposes to Delay MDR by a Year Due to COVID-19

Amending Regulation (EU) 2017/745 on medical devices as regards the dates of application of certain of its provisions Reasons for and objectives of the proposal Regulation (EU) 2017/745 of the European Parliament and of the Council, adopted on 5 April 2017,...

Advancing regulatory science in the EU – new strategy adopted

Advancing regulatory science in the EU – new strategy adopted

Press release 31/03/2020 EMA has published its Regulatory Science Strategy to 2025  today. The strategy provides a plan for advancing regulatory science over the next five years, covering both human and veterinary medicines. It comes in response to the dramatic...

EU GMP Annex 21 finally published

EU GMP Annex 21 finally published

On 20 March, after some delays, the new Annex 21 to the EU-GMP Guidelines was published as a draft This Annex summarizes the GMP requirements applicable to a Manufacturing Import  Authorisation (MIA) holder which imports medicinal products (human and veterinary)  from...

Formação CTD MODULO 3: Formação de excelente qualidade !

Formação CTD MODULO 3: Formação de excelente qualidade !

No passado dia 4 de março teve lugar a 2ª edição da formação sobre o CTD MODULO 3,  conduzida pelo reconhecido especialista Dr Pedro Fins Pereira, Gestor de PRM e PDC / MRP/DCP Procedure Manager, da Direção de Avaliação de Medicamentos/Unidade de Manutenção no...

Explanatory Note to GVP Module VII

Explanatory Note to GVP Module VII

The following explanatory note to Good Pharmacovigilance Practices (GVP) Module VII aims at addressing the challenges encountered during the two years of running the PSUSA process. Ultimately, the explanatory note will serve as the basis for the update of GVP Module...

EMA  Implementation of ICH Q12 Guideline

EMA Implementation of ICH Q12 Guideline

ICH Q12 Technical and regulatory considerations for pharmaceutical product lifecycle management   Globalisation of the supply chain and market for medicinal products has resulted in a growing number of different procedures, rules and regulations which MA Holders...

Falsified Medicines: New EU Aide Memoire for GDP

Falsified Medicines: New EU Aide Memoire for GDP

The European Commission has published an aide memoire for Good Distribution Practices (GDP) inspection of wholesalers’ compliance with Commission Delegated Regulation (EU) 2016/161 for safety features. The six-page document has been available online since 18 November...

European Commission publishes revised Annex 1

European Commission publishes revised Annex 1

Second targeted stakeholders' consultation on the revision of Annex 1, on manufacturing of sterile medicinal products, of Eudralex volume 4 Period of consultation : From 20 February 2020 to 20 May 2020. Objective of the consultation Annex 1 was first published in...