Voltar 16 jul 2020
  • Novidades 16 de julho 2020 0

EC – EUROPEAN COMISSION

(No new developments)

 

 

 

ECA - EUROPEAN COMPLIANCE ACADEMY

 

 

New Brazilian ANVISA Guide for the Validation of Computerised Systems

On 14 April 2020, the Brazilian regulatory authority ANVISA published a new guideline for the validation of computerised systems which is to replace the guideline of the same name from 2010. Find out more about the main contents and further developments here.

Regulatory Authorities worldwide work more closely together because of COVID-19

Regulatory authorities around the world want to work together more closely on the basis of Covid-19 and have identified three areas for this: research during pregnancy, medicines in clinical trials and monitoring of vaccines. 

FDA Warning Letter due to Lack of Validation of the Aseptic Manufacturing Process

In this Warning Letter from the FDA to a manufacturer of unauthorised tissue-based products, deficiencies in current Good Tissue Practice (cGTP) and violations of fundamental GMP regulations are described.  

 

 

 

EDQM 

 

Last chance to comment: analysis of N-nitrosamine impurities

Given the exceptional circumstances due to the COVID-19 pandemic, we would like to remind stakeholders who were not able to provide comments before the end of June to contact their respective national pharmacopoeia authority (NPA) or the EDQM as soon as possible so as to announce their intent to comment (see also the news from 15 April 2020). The general chapter on the analysis of N-nitrosamine impurities in active substances (2.4.36) will remain available in the Pharmeuropa archives issue 32.2 and comments must be sent no later than 31 August 2020.

EDQM’s actions to evaluate impact of the detection of an impurity in the active substance paracetamol

Following the publication of an article in the Dutch newspaper Nieuwe Rotterdamsche Courant Handelsblad (NRC) concerning an impurity (4-chloroaniline) in the active substance paracetamol manufactured by a specific company which holds a certificate of suitability, the EDQM is actively working with the company and other stakeholders to better understand the potential impact of this impurity and the extent of the issue.

 

 

EMA - EUROPEAN MEDICINES AGENCY

 

Guidance for medicine developers and companies on COVID-19 (updated)

 

 

COVID-19: What's new (updated)

 

 

Validation checklist for initial marketing authorisation applications – pharmaceuticals (applicable to submissions under Art. 12(3) of Directive 2001/82 (updated)

 

 

Launch of public consultation on joint network strategy to 2025

EMA and the Heads of Medicines Agencies (HMA) have developed a joint strategy for the next five years that is released for a two-month public consultation today.

 

Regulatory and procedural guideline: List of centrally authorised products requiring a notification of a change for update of annexes (updated)

 

 

 

FDA

 

July 6, 2020 - Coronavirus (COVID-19) Update: Daily Roundup July 6, 2020 

Coronavirus (COVID-19) Update: Daily Roundup June 2, 2020

The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic.



 

GDP Association

 (No new developments)

 

 

 

HMA

HMA, EMA AND THE EUROPEAN COMMISSION WORKING AGAINST COVID-19

HMA supports the development and approval of treatments and vaccines to combat coronavirus since the start of the outbreak. Therefore, our colleagues in National Competent Authorities, the European Medicines Agency and the European Commission are working in partnership and contributing their knowledge.

 

LAUNCH OF PUBLIC CONSULTATION ON JOINT NETWORK STRATEGY TO 2025

EMA and the Heads of Medicines Agencies (HMA) have developed a joint strategy for the next five years that is released for a two-month public consultation today. The draft strategy details how the European medicines agencies’ network can continue to enable the supply of safe and effective medicines that meet patients’ needs in the face of challenges posed by ever-accelerating developments in science, medicine, digital technologies, globalisation as well as emerging health threats, such as the COVID-19 pandemic.

 

 

 

HMA - CMDH

HMA, EMA and the European Commission working against COVID-19


Requirements on submissions (number and format) for New MA Applications within MRP, DCP or National procedures (June 2020)

Notification Form (June 2020)  

 

Cover letter for Variation Applications in the Mutual Recognition Procedure

 

Cover letter for new applications submitted through MRP/DCP

 

 

 

ICH

 

The ICH M7(R2) Q&A draft document presentation available now on the ICH website


The ICH M7(R2) Q&A draft document reached Step 2b of the ICH Process in June 2020 and now enters the consultation period. Additionally, a Step 2 Informational Presentation has also been developed by the M7(R2) Maintenance EWG/IWG.



 

INFARMED

 

Atualização da lista de grupos homogéneos e preços de referência

No âmbito do Sistema de Preços de Referência, a lista dos grupos homogéneos e dos preços de referência unitários, a vigorar no 3.º trimestre de 2020, foi atualizada.

 

Decreto-Lei n.º 36/2020 - Diário da República n.º 136/2020, Série I de 2020-07-15

Simplifica o procedimento de licenciamento dos estabelecimentos industriais de fabrico de dispositivos médicos, equipamentos de proteção individual, álcool etílico e produtos biocidas desinfetantes.

Resolução do Conselho de Ministros n.º 53-A/2020 - Diário da República n.º 135/2020, 2º Suplemento, Série I de 2020-07-14

O comité de medicamentos para uso humano (CHMP) da Agência Europeia de Medicamentos (EMA, na sigla inglesa) emitiu um parecer exigindo aos laboratórios da indústria farmacêutica que tomem medidas para limitar o máximo possível, a presença de nitrosaminas em medicamentos de uso humano e para garantir que os níveis dessas impurezas não excedam os limites estabelecidos.

 

Comunicado de Imprensa - EMA finaliza parecer sobre presença de nitrosaminas em medicamentos

O comité de medicamentos para uso humano (CHMP) da Agência Europeia de Medicamentos (EMA, na sigla inglesa) emitiu um parecer exigindo aos laboratórios da indústria farmacêutica que tomem medidas para limitar o máximo possível, a presença de nitrosaminas em medicamentos de uso humano e para garantir que os níveis dessas impurezas não excedam os limites estabelecidos.

 

Comunicado de Imprensa - Criado Grupo de Trabalho para a facilitação de dispensa de medicamentos hospitalares

O Infarmed vai liderar o Grupo de Trabalho constituído pelo despacho da Secretária de Estado Adjunta e da Saúde, de 30 de junho, que terá como objeto os modelos de dispensa de proximidade de medicamentos.

 

 

 

EFPIA - European Federation of Pharmaceutical Industries and Associations

 (No new developments)

 

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