Voltar 17 jan 2020
  • Novidades 17 de Janeiro de 2020 0

EC - EUROPEAN COMISSION

 

(no new develpoments)

 

 

ECA - EUROPEAN COMPLIANCE ACADEMY

 

Clinical Trials Regulation Questions & Answers Version 2.3

The European Commission (EC) published an updated Version 2.3 of the Questions & Answers relating to the Clinical Trials Regulation.

 

 

From GVP to GMP: MHRA´s tips for QPs to stay compliant

The MHRA recently posted three top tips for protecting patients and staying compliant when introducing updates to patient information leaflet.

 

 

FDA Warning Letter for Chinese Manufacturer highlights the Importance of the Quality Unit

The U.S. Food and Drug Administration (FDA) has issued a warning letter to Henan Kangdi Medical Devices Co. Ltd. due to, among others, the failure to establish an adequate stability program. Furthermore, the quality unit was not provided with the appropriate authority and sufficient resources to carry out its responsibilities.

 

 

Warning Letter for inadequate OOS Investigations and Complaint Handling

The U.S. Food and Drug Administration (FDA) recently warned Teligent Pharma, Inc., for different significant violations of current good manufacturing practice (CGMP) at the company's facility in Buena, New Jersey. The FDA cites the company, among others, for failing to thoroughly investigate out-of-specification (OOS) test results.

 

 

Risk Management Standard for Medical Devices ISO 14971:2007 revised

The currently valid ISO 14971 of 2007 will now be replaced by the version from 2019 (revision 3). The standard is applicable to all phases of a medical device´s life cycle. What is new?

 

 

 

EDQM 

 

Monograph on Rosuvastatin tablets (3008) published in Ph. Eur. Supplement 10.1

The European Pharmacopoeia Commission adopted a new monograph, on Rosuvastatin tablets (3008), at its 163rd session in March 2019.

 

 

Soon to come: new Pharmeuropa website

The EDQM would like to inform you that a new version of the Pharmeuropa website will go live on 23 January 2020. This website will include new features, such as single sign-on for users with access to the European Pharmacopoeia 10th Edition online.

 

 

EMA - EUROPEAN MEDICINES AGENCY

Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 13-16 January 2020

At its January meeting, EMA’s safety committee recommended that patients stop using Picato (ingenol mebutate), a gel for treating the skin condition actinic keratosis, while it continues its review of the medicine’s safety.

 

 

Mandatory use of international standard for the reporting of side effects to improve safety of medicines

The use of the new international standard will become mandatory as of 30 June 2022 for all reporting to EudraVigilance, the European database of suspected side effects with medicines authorised in the European Economic Area (EEA).

 

 

Questions and answers on impact of European Union-United States mutual recognition agreement on marketing authorisation applications and relevant variations

 

 

 

FDA

 

UPDATE - FDA alerts patients and health care professionals to two voluntary recalls of ranitidine

FDA is alerting patients and health care professionals to two voluntary recalls of ranitidine. The medicines are being recalled because they may contain unacceptable levels of N-nitrosodimethylamine (NDMA).

 

 

 

GDP ASSOCIATION

 

(No new developments)

 

 

  

HMA

 

(No new developments)

 

 

 

HMA - CMDH

 

Decentralised Procedure - Requests to act as RMS

The Heads of Medicines Agencies’ Task Force on Resources in DCP in cooperation with CMDh has developed a common request form to be used when asking a National Competent Authority (NCA) to act as Reference Member State in a decentralised procedure. The Heads of Medicines Agencies has agreed to publish the request form on the CMDh website as well as on all national competent authorities websites.

 

 

Information on national timeslot booking systems and recommendations for requests to act as RMS (January 2020)

The Heads of Medicines Agencies’ Task Force on Resources in DCP in cooperation with CMDh has developed a common request form to be used when asking a National Competent Authority (NCA) to act as Reference Member State in a decentralised procedure. The Heads of Medicines Agencies has agreed to publish the request form on the CMDh website as well as on all national competent authorities websites.

 

 

 

ICH

 

ICH M9 and Q&As reach Step 4 of the ICH Process (Updated: 4/12/2019)

The ICH M9 Guideline and Q&As provide recommendations to support the biopharmaceutics classification of medicinal products and to support the waiver of bioequivalence studies. This Guideline will reduce the costs and time of development and prevent unnecessary exposure of mostly healthy volunteers to medicinal products, as in vivo studies to prove the biopharmaceutical quality of the medicinal product would not be needed, and therefore, facilitate the patient’s access to medicines or post-approval changes.

 

 

 

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 4.º trimestre de 2019, foi atualizada.

 

 

Disponível webservice para notificação de faltas de medicamentos

Conforme previsto no Regulamento de Gestão da Disponibilidade do Medicamento, o webservice para comunicação automática das faltas de medicamentos está disponível.

 

 

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