Voltar 14 jun 2021
  • Novidades 29 de Novembro de 2019 0

EC - EUROPEAN COMISSION

 

Open borders that prioritise essential goods key to medicines supply in Europe

The renewed EU Schengen strategy includes many of the lessons learned from COVID-19 (…)

 

 

Too much at stake in the EU pharma strategy to get it wrong: how the EU can deliver equitable access to medicines

 Christoph Stoller, President of Medicines for Europe (Teva)

 

 

 

ECA - EUROPEAN COMPLIANCE ACADEMY

 

Herbal Drugs - What is Well-Established Use?

Herbal medicinal products can be registered via the well established use approach within the EU. But what is needed for the simplified registration and how to demonstrate well established use?

 

 

Foreign Matter in Herbal Drugs

A revised version of Ph. Eur. Chapter 2.8.2 Foreign Matter is available. It clarifies the requirements for other foreign matter like moulds and animal contamination and any other unwanted matter (e.g. glass, metal, plastic).

 

 

International Inspections: TGA and the Management of GMP Compliance Signals

The Australian Therapeutic Goods Administration (TGA) has published a guidance on the management of so-called GMP compliance signals for domestic and foreign manufacturers of medicinal products and biological products.

 

 

Copies in the GMP Environment / True Copies

Copies play an important role in the GMP environment. They are used every day. And they are a data integrity issue par excellence. Where to find references to this in the regulations?

 

 

The GMP Requirements for Supplier Qualification

Supplier Qualification is more than auditing. Supplier qualification can be seen as a risk assessment tool. It should provide an appropriate level of confidence that suppliers, vendors and contractors are able to supply consistent quality of materials, components and services in compliance with regulatory requirements. An integrated supplier qualification process should also identify and mitigate the associated risks of materials, components and services. But what are the exact requirements?

 

 

New USP Chapter on Visual Inspection of Parenterals?

In the current Pharmaceutical Forum PF 47(3), a Stimuli article describes the weaknesses of the current specifications for the inspection of parenterals for particles and how these could be dealt with in a new USP chapter.

 

 

Unexpected Deviations and the Role of the QP

Annex 16 to the EU-GMP Guidelines (Certification by a Qualified Person and Batch Release) states in section 3 that "provided registered specifications (…) are met, a QP may consider confirming compliance or certifying a batch where an unexpected deviation concerning the manufacturing process and/or the analytical control methods from details contained within the MA and/or GMP has occurred". But what exactly are "registered specifications"? And can we deviate from in-process controls?

 

 

 

EDQM

 

Sign up today! EDQM Virtual Training Programme - Modules on Ph. Eur., RS & CEP Procedure

This virtual training will focus on chemically defined substances and cover all the fundamentals related to the use of the European Pharmacopoeia (Ph. Eur.) and its reference standards, as well as the procedure for Certification of suitability to the monographs of the European Pharmacopoeia (CEP).

 

 

Certification monthly report of activities: May 2021

The latest monthly activity report for the Certification of Substances Department (DCEP) is now available.

 

 

 

EMA - EUROPEAN MEDICINES AGENCY

Other: Membership list - HMA / EMA joint Big Data Steering Group (updated)

 

Supply shortage: Shortage of Vfend (voriconazole) supply shortage  (updated)

 

Other: Frequently asked questions about parallel distribution 

 

Regulatory and procedural guideline: Checklist for annual updates for parallel distribution: guidance for industry (updated)

 

Regulatory and procedural guideline: Checklist for annual updates for parallel distribution: guidance for industry 

 

 

 

FDA

June 7, 2021 - FDA Grants Accelerated Approval for Alzheimer’s Drug

 

 

June 4, 2021 - FDA Approves First Treatment for Patients with Plasminogen Deficiency, a Rare Genetic Disorder

 

 

 

GDP ASSOCIATION

(No new developments)

 

 

 

HMA

(No new developments)

 

 

 

HMA - CMDH

 

This is the 'Recently Published' page for the Human Medicines section

Added in June 2021  

 

NEW - HaRP assessment reports for olmesartan/amlodipine and etofenamate

 

 

 

 

 

 

 

 

ICH

 

(No new developments)

 

 

 

 

INFARMED

 

Novo Regulamento dos Dispositivos Médicos: novas características

 

Partilhe este artigo nas redes sociais