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Questions and answers (version 17) - Safety features for medicinal products for human use





UK Changes Import Restrictions for Cannabis

UK will implement faster access to medicinal cannabis as import restrictions are changed. Thus, patients will be able to get their treatment in days rather than months.



Lying in an Inspection? Not a good Idea!

A Chinese company was placed on import alert by FDA because investigators observed significant deviations from cGMP. In some cases, the company told the untruth.



EU implementation of ICH Q12

Following the adoption of the ICH Q12 Guideline in November 2019 the EMA recently published the ICH Q12 Step 5 Guideline and its annexes - together with an Explanatory Note.




EDQM laboratory obtains ISO 17025:2017 accreditation

The EDQM Laboratory successfully obtained accreditation for the 2017 version of the ISO 17025 standard from the Belgian accreditation organisation BELAC in February 2020, confirming the validity of the results generated for its Ph. Eur. reference standards.




Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 9-12 March 2020

At its monthly meeting, EMA’s safety committee (PRAC) has started a review of medicines containing ifosfamide to examine whether there is a higher risk of encephalopathy (brain disorder) with ifosfamide available as a ready-made solution or concentrate for solution than with the powder form.


Monitoring the Adequacy of Implementation and Adherence to International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Guidelines

The aim of this study is to monitor the adequacy of implementation and adherence to ICH Guidelines by regulatory authorities


Coronavirus disease (COVID-19) Overview page. Updated daily.


COVID-19: EMA meetings with delegates and experts will be held virtually until end April 2020

As a precautionary measure, all meetings of EMA committees and working parties will be held virtually until the end of April 2020.




Coronavirus (COVID-19) Update: FDA gives flexibility to New York State Department of Health, FDA issues Emergency Use Authorization diagnostic

Yesterday, the U.S. Food and Drug Administration took two significant actions in the agency’s ongoing and aggressive commitment to address the coronavirus outbreak (COVID19).






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Decentralised Procedure - Requests to act as RMS (Update)






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Atualização da lista de medicamentos abrangidos pela notificação prévia de exportação ou distribuição para outros Estados-membros

Na sequência de emergência de Saúde Pública de âmbito Internacional declarada pela Organização Mundial de Saúde em 30/01/2020 para infeção por SARS-CoV-2 (novo coronavírus 2019) foi decidido constituir uma Reserva Estratégica de Medicamentos (REM) destinada a todo o território nacional.




EFPIA update on research-based pharmaceutical industry response to COVID-19

The advent of a global health emergency such as coronavirus underlines the need for a collaborative, dynamic, responsive and empowered research eco-system in Europe.


EFPIA response to the publication of the EU Industrial Strategy

EFPIA notes the publication of the Industrial Strategy by the European Commission including a reference to the roadmap to the EU Pharmaceutical Strategy, which will be published tomorrow.


The EU’s Industrial Strategy: Will Europe smile or will she not smile; that is the question

What the EU’s industrial policy can do is enhance the strengths already present in the EU economy and create a stronger and more innovation-friendly framework environment to support EU competitiveness.




Coronavirus crisis: “Commission will use all the tools at its disposal to make sure the European economy weathers the storm”

The crisis we face because of Coronavirus has both a very significant human dimension, and a potentially major economic impact. It is therefore essential that we act decisively and collectively, to contain the spread of the virus and help patients, and to counter the economic fallout.


COVID-19 European Comission Latest developments page




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