Voltar 04 jun 2019
  • Novidades (02 a 09 de Junho) 0

EC - EUROPEAN COMISSION

Quality of medicines: Korean active substances in line with EU standards

 A Commission decision adopted today will contribute to improving the quality of medicines in the EU by ensuring the quality of active substances produced in the Republic of Korea are in line with EU standards.

 

 

ECA - EUROPEAN COMPLIANCE ACADEMY

Warning Letter on Data Integrity Issues in the Microbiological Laboratory

Among other things, insufficient or missing reports of test results in a microbiological laboratory resulted in a Warning Letter addressed to the company concerned. Read more about the Warning Letter to Hospira Healthcare India Pvt.

  

How does the GDPR impact Clinical Trials?

The European Commission released a Question and Answers paper on the interplay between the Clinical Trials Regulation (CTR) and the General Data Protection Regulation (GDPR).

 

Numerous GMP Deviations found at US Manufacturing Site

Due to the deficiencies discovered during an inspection performed in July 2018, the US FDA has now issued a Warning Letter to a US pharmaceutical manufacturer of homeopathic drug products. Microbiological impurities in the products and the water used to manufacture the medicinal products are an essential aspect of the complaint.

 

GDP-Inspector: Why Supplier Qualification is important

The MHRA explains in a Blog what supplier qualification means and why it is necessary to do it comprehensively.

 

New office-based GDP-Inspection Process in UK

The U.K. Medicines and Health Products Agency (MHRA) is testing a new, office-based GDP-Inspection process - without a visit of the site.

 

Recent GMP defects in process validation

What are the authorities' requirements regarding process validation? Regulatory GMP inspection reports are useful in answering that question. The "Freedom of Information Act" obliges the US FDA to publish all inspection results. The FDA does that particularly when it comes to warning letters.

 

Fundamental GMP defects by manufacturer of homeopathic drugs

Due to fundamental GMP deficiencies, the FDA has issued a Warning letter to a US manufacturer of homeopathic drugs. Read more here.

 

GDP-Inspector: Why Supplier Qualification is important

The MHRA explains in a Blog what supplier qualification means and why it is necessary to do it comprehensively.

 

New office-based GDP-Inspection Process in UK

The U.K. Medicines and Health Products Agency (MHRA) is testing a new, office-based GDP-Inspection process - without a visit of the site.

 

New WHO Draft for GDP Guidance

The World Health Organisation WHO plans to revise its Good Storage and Distribution Practice guidelines and to consolidate the rules in one single document.

 

GMP Deficiencies at Topical Products Manufacturer

The FDA has recently issued a Warning Letter to a US manufacturer of OTC topical products describing serious GMP deficiencies. This concerns among others the water system, the QC (chemical, microbial and stability tests), and the process validation.

 

Revised USP chapter

Topical and Transdermal Product Quality Tests

The revised USP general chapter TOPICAL AND TRANSDERMAL DRUG PRODUCTS - PRODUCT QUALITY TESTS has been approved.

 

WHO plans Inclusion of environmental Aspects in GMP

The WHO has published a draft document on "Environmental Aspects of GMP" and plans to include the topic of waste and wastewater management into GMP Guidance.

 

 

EDQM

(No new developments)

 

 

EMA - EUROPEAN MEDICINES AGENCY

Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 13-16 May 2019

 

EMA Regulatory Science to 2025 - Strategic reflection

The European Medicines Agency's (EMA) draft 'Regulatory Science to 2025' strategy is a plan for advancing EMA's engagement with regulatory science over the next five to ten years, covering both human and veterinary medicines. In December 2018, EMA published the draft strategy for a six-month public consultation.

 

Consultation on draft guideline on quality requirements for medical devices in combination products

EMA has released a draft guideline on the quality requirements for medical devices in human medicines that include a medical device, known as drug-device combinations, for a 3-month public consultation.

 

Consultation on draft guideline on quality requirements for medical devices in combination products

EMA has released a draft guideline on the quality requirements for medical devices in human medicines that include a medical device, known as drug-device combinations, for a 3-month public consultation.

 

 

FDA

FDA approves first anticoagulant (blood thinner) for pediatric patients to treat potentially life-threatening blood clots

 

 

GDP ASSOCIATION

(No new developments)

 

 

HMA

Contact points for requests for exemption to continue batch control testing in the United Kingdom (UK) after UK's withdrawal from the Union for a nationally authorised medicinal product

 

 

HMA - CMDH

(No new developments)

 

 

ICH

(No new developments)

 

 

INFARMED

Implementação das obrigações legais no que respeita aos dispositivos de segurança

A implementação da Diretiva 2011/62/EU, "Diretiva dos Medicamentos Falsificados" e do Regulamento Delegado (UE) 2016/161, da Comissão, de 2 de outubro de 2015, pelos estados membros da União Europeia alterou significativamente o circuito do medicamento, não só pela obrigatoriedade de colocação de dispositivos de segurança nas embalagens de determinados medicamentos, permitindo a deteção de medicamentos falsificados na cadeia legal, mas também pelas novas obrigações legais aplicáveis a fabricantes, titulares de autorização de introdução no mercado de medicamentos, distribuidores por grosso, farmácias e serviços farmacêuticos hospitalares.

 

Lista de grupos homogéneos e preços de referência atualizada

No âmbito do Sistema de Preços de Referência, a lista dos grupos homogéneos e dos preços de referência unitários, a vigorar no 2.º trimestre de 2019, foi atualizada.

 

Publicação das retificações dos regulamentos relativos aos dispositivos médicos (MDR) e aos dispositivos médicos para diagnóstico in vitro (IVDR)

Em 3 de maio de 2019, foi publicada no Jornal Oficial da União Europeia (Eur-Lex: Direito da UE), a versão portuguesa de algumas retificações aos regulamentos aplicáveis aos dispositivos médicos. As referidas retificações resultaram de um processo de discussão conjunta entre os Estados-membros, a Comissão Europeia e o Conselho Europeu, as quais abrangem alguns aspetos técnicos e de natureza editorial.

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