Voltar 23 nov 2020
  • Novidades 17 de Junho de 2019 0

EC - EUROPEAN COMISSION

(No new developments)

 

 

ECA - EUROPEAN COMPLIANCE ACADEMY

Brexit: Phased Process for implementing Medicines Regulation in Northern Ireland

An agreed approach had been reached on a phased process for implementing medicines regulation in Northern Ireland up to 31 December 2021.

 

WHO Draft Document on GMP for IMPs

In view of recent experiences from inspections carried out for COVID-19 therapeutics, the World Health Organization (WHO) published a new working document entitled "GOOD MANUFACTURING PRACTICES FOR INVESTIGATIONAL PRODUCTS".

 

What do Authorities expect from Cleaning in the GMP Area?

Cleaning is an important process step in the field of pharmaceutical production. So what are the requirements for GMP-compliant cleaning from the perspective of the authorities? A current FDA Warning Letter provides information on this.

 

 

EDQM

New EDQM document on recombinant viral vectored vaccines to support COVID-19 vaccine developers

A broad range of technologies are being evaluated in the development of COVID-19 vaccines, from conventional approaches, such as live attenuated and inactivated vaccines, to more recent technologies, such as nucleic acid vaccines and recombinant viral vectored vaccines. Currently, limited guidance is available covering the quality of such new technologies.

 

 

EMA - EUROPEAN MEDICINES AGENCY

Report: Recommendations on eligibility to PRIME scheme - Adopted at the CHMP meeting of 9-12 November 2020 (new)

 

News and press releases: Nitrosamines: EMA aligns recommendations for sartans with those for other medicines

 

Referral: Angiotensin-II-receptor antagonists (sartans) containing a tetrazole group , valsartan, candesartan, irbesartan, losartan and olmesartan , Article 31 referrals, Opinion provided by Committee for Medicinal Products for Human Use, 12/11/2020, 13/11/2020 (updated)

 

Periodic safety update single assessment: Phenylephrine (ophthalmic formulations): List of nationally authorised medicinal products - PSUSA/00010402/202001 (new)

 

Periodic safety update single assessment: Levonorgestrel/ethinylestradiol, ethinylestradiol (combination pack): CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00010442/202001 (new)

 

 

FDA

Coronavirus (COVID-19) Update: FDA Authorizes Drug Combination for Treatment of COVID-19

Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the drug baricitinib, in combination with remdesivir, for the treatment of suspected or laboratory confirmed COVID-19 in hospitalized adults and pediatric patients two years of age or older requiring supplemental oxygen, invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).

 

FDA Offers Guidance to Enhance Diversity in Clinical Trials, Encourage Inclusivity in Medical Product Development

 

 

GDP ASSOCIATION

(No new developments)

 

 

HMA

HMA/EMA STATEMENT ON APPROVAL OF VACCINES

Development and deployment of safe and effective vaccines is seen as an essential element in the management and solution of the COVID-19 pandemic. In continuation hereof, the European Medicines Agency (EMA) and Heads of Medicines Agencies (HMA) have prepare a joint statement on how COVID-19 vaccine applications should be assessed.

 

 

HMA - CMDH

UPDATE - Data requested for New Applications in the MRP/DCP which are not stated in the current EU legislation and/or in Volume 2B, Presentation and format of the dossier Common Technical Document (CTD) and/or in the EEA approved Guidelines/Recommendation papers;

 

UPDATE - Requirements on submissions (number and format) for New MA Applications within MRP, DCP or National procedures;

 

UPDATE - Requirements on submissions (number and format) for Variations and Renewals within MRP and National procedures

 

 

ICH

(No new developments)

 

 

INFARMED

EMA publica documento sobre critérios de desenvolvimento e avaliação clínica das vacinas contra a COVID-19

No âmbito da avaliação das vacinas contra a COVID-19, e tendo em conta a necessidade de atualização face aos mais recentes desenvolvimentos nesta área, o Infarmed vem pelo presente comunicar que a Agência Europeia de Medicamentos (EMA na sigla em inglês), publicou o documento "EMA considerations on Covid-19 vaccine approval", onde são apresentados os critérios base aplicáveis ao desenvolvimento e avaliação dos dados clínicos para aprovação das vacinas contra a COVID-19.

 

Revogação da suspensão da autorização de distribuição por grosso de medicamentos de uso humano - Divisioncare Unipessoal, Lda. - A011-19-H-001-2019

O Conselho Diretivo informa da decisão de revogação da suspensão da autorização de distribuição por grosso de medicamentos de uso humano - Divisioncare Unipessoal, Lda.- A011/19/H/001/2019, uma vez que o distribuidor em causa já se encontra ligado ao sistema de repositórios.

 

Indisponibilidade de medicamentos contendo esomeprazol, 40 mg, pó para solução injetável ou para perfusão

Na sequência da rutura dos medicamentos contendo esomeprazol, 40 mg, pó para solução injetável ou para perfusão, e por forma a racionalizar as embalagens existentes, recomenda-se que este medicamento apenas seja utilizado nos casos em que não seja possível a sua substituição pela via oral ou por outros inibidores da bomba de protões.

 

Portaria n.º 270/2020 - Diário da República n.º 226/2020, Série I de 2020-11-19

Regulamenta as matérias relativas à publicitação de procedimento concursal, prazos, forma de apresentação de candidatura, notificações e utilização de meios eletrónicos.

 

Novos vídeos do Sistema de Informação para Dispositivos Médicos (SIDM).

http://www.23.miktd6.com/vl/267-02afe6ad992719cdd-f6b5651bc8df71731dfemveLFo8e1M4e748da72956

 

 

EFPIA – European Federation of Pharmaceutical Industries and Associations

European Alliance formed to put value and outcomes at centre of health systems

 

Today, 11 associations form the European Alliance for Value in Health. The Alliance represents a broad group of European associations representing patients, scientific and professional societies, healthcare managers, hospitals, regional health authorities and life-science industries.

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