Voltar 13 set 2019
  • Novidades 13 de Setembro de 2019 0

EC - EUROPEAN COMISSION

(No new developments)

 

ECA - EUROPEAN COMPLIANCE ACADEMY

 

EU: first Steps to face Drug Shortages

The European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) published two guidance documents which can be seen as foundation for a long way to diminish shortages of medicinal products.

 

 

EDQM

 

Ph. Eur. 10th Edition - Now available

The 10th Edition of the European Pharmacopoeia, which is applicable in 38 European countries from 1 January 2020 and is used in over 100 countries worldwide, is now available!

 

 

EMA - EUROPEAN MEDICINES AGENCY

EMA to provide guidance on avoiding nitrosamines in human medicines

EMA’s Executive Director has asked the human medicines committee (CHMP) to provide guidance for avoiding the presence of nitrosamine impurities in human medicines containing chemically synthesised active substances.

 

Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 2-5 September 2019

EMA’s safety committee (PRAC) has started a review of data on skin cancer in patients using Picato (ingenol mebutate), a gel for treating actinic keratosis, a skin condition caused by too much sunlight exposure.

 

Temporary interim limits for NMBA, DIPNA and EIPNA impurities in sartan blood pressure medicines

The risks associated with the presence of the nitrosamines N-nitrosodimethylamine (NDMA) and Nnitrosodiethylamine (NDEA) in sartan blood pressure medicines (angiotensin II receptor blockers) containing a tetrazole ring have been assessed in a referral under Article 31 of Directive 2001/83/EC within procedure EMEA/H/A-31/1471.

 

Generic and hybrid applications

The European Medicines Agency (EMA) assesses applications from companies to market generic medicines in the European Union (EU). To help applicants, EMA has published questions and answers (Q&As) on its position on issues applicants preparing to request marketing authorisation for generic or hybrid medicines typically raise.

 

Biosimilar medicines: marketing authorisation

A biosimilar is biological medicine highly similar to another already approved biological medicine in the European Union (EU), for which marketing exclusivity rights have expired. The European Medicines Agency (EMA) is responsible for evaluating the majority of applications to market biosimilar medicines before they can be approved and marketed in the EU.

 

FDA

Statement alerting patients and health care professionals of NDMA found in samples of ranitidine

The U.S. Food and Drug Administration has learned that some ranitidine medicines, including some products commonly known as the brand-name drug Zantac, contain a nitrosamine impurity called N-nitrosodimethylamine (NDMA) at low levels. 

 

GDP ASSOCIATION

(No new developments)

 

 

HMA

(No new developments)

 

 

HMA - CMDH

 

List of safety concerns per approved Risk Management Plan (RMP) of active substances per product

 

ICH

(No new developments)

 

INFARMED

 

Alterações ao Estatuto do Medicamento - Decreto-Lei n.º 112/2019, de 16 de agosto

Circular Informativa n.º 136/CD, de 26/08/2019

No seguimento da entrada em vigor do Decreto-Lei n.º 112/2019, de 16 de agosto, que procedeu à décima segunda alteração ao Decreto-Lei n.º 176/2006, de 30 de agosto (Estatuto do Medicamento), destacam-se as seguintes alterações.

 

 

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