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ECA - EUROPEAN COMPLIANCE ACADEMY

Eurasian Pharmacopoeia Available

The Eurasian Economic Commission published Volume 1 of the EAEU Pharmacopoeia. This Volume contains 157 general texts and general monographs.

  

Inspection Observations on Supplier Qualification because of Inspection at Supplier

A US company received an FDA Warning Letter because of problems at their CMO that were not detected in time.

 

New USP Draft Chapter on Plastic Components Used in Manufacturing

In the current Pharmacopeial Forum revised drafts of the two previously published USP Chapters <665> and <1665> on plastic materials used in pharmaceutical manufacturing have been published for comment.

 

Brexit: How to import Medicines into UK

The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has just published a Guidance for Wholesaling and Importing Activities after the end of the Transition Period.

 

FDA Warning Letters: Structure and the "Lessons Learnt" Effect

The unpopular deficiency letters of the FDA contain numerous standard formulations and follow a fixed scheme in their structure. Read more here about the structure of the Warning Letters and why their reading can be very useful in preparing for an FDA inspection. 

Swissmedic resumes Inspections

Swissmedic has announced that inspections will again be carried out on site, provided that appropriate protective measures are observed.

 

 

EDQM

New approach for extraneous agent testing in IVMPs: the EDQM provides further support to its users over the long term

To provide long-term user support on IVMP testing policy, the EDQM is making two documents available. The first summarises what has changed and why, the second summarises the content of the training webinars which took place on 1 April 2020. 

 

10 years of collaboration between the European Commission and the EDQM in the field of blood

Blood transfusion is a life-saving measure: more than 25 million units of blood are transfused per year in Europe and nearly 1 400 blood establishments (BEs) are involved in the supply of blood in Europe on a daily basis.

 

Vacancy at the EDQM: Lyophilisation Manufacturing Manager

The European Directorate for the Quality of Medicines & HealthCare (EDQM) is looking for a highly qualified manufacturing project co-ordinator with strong communication skills and in-depth experience in freeze-drying (lyophilisation) to join its Manufacturing team.

 

Update on the review of the CEP application regarding an impurity in the active substance paracetamol

The EDQM has concluded its investigation following reports that paracetamol manufactured by a specific company holding a certificate of suitability could be contaminated with the impurity 4-chloroaniline (PCA).

 

Nitrosamines risk assessment: update for CEP holders
In October 2019, the EDQM requested companies holding CEPs to perform a risk assessment of their chemically synthesised APIs with regard to potential nitrosamine formation, using quality risk management principles. It was highlighted that the factors to be taken into account were outlined in the dedicated Questions and Answers documents available on the EMA and CMDh websites.

 

EMA - EUROPEAN MEDICINES AGENCY

 

Newsletter: News bulletin for small and medium-sized enterprises - Issue 50

 

Applications for new human medicines under evaluation by the CHMP: September 2020

This document lists information on applications for centralised marketing authorisation for human medicines that the European Medicines Agency has received for evaluation. It includes the international non-proprietary names (INN) and therapeutic areas for all new innovative medicines under evaluation by the Committee for Medicinal Products for Human Use (CHMP). 

Minutes of the 108th meeting of the Management Board: 11 June 2020 (new)

Held in Amsterdam on 11 June 2020.

Pre-authorisation guidance (updated)

 

 

GDP ASSOCIATION

European GDP Association nominates new Board Member

The European GDP Association, representing more than 2,200 professionals from across the globe, has extended its Board. Emil Schwan was invited to join the Board and accepted his nomination.

GDP Monograph for Active Substances: Interactive PDF now available

The "Good Distribution Practice for Active Substances Guidance on interpretation and implementation" has been published recently as a joint publication of the ECA Foundation's GDP Association and the Pharmaceutical Quality Group of the Chartered Quality Institute. An interactive PDF of the document is now accessible free of charge in the member's area of the European GDP Association.

 

 

HMA - CMDH

Examples for acceptable and not acceptable groupings for MRP/DCP products (July 2020)

As a general rule, type IA or IAIN variations for the implementation of safety-relevant changes may not be grouped together with type IB or type II variations as this would delay the implementation of this safety-relevant information.

 

List of safety concerns per approved Risk Management Plan (RMP) of active substances per product  (August 2020)


 

ICH

The ICH E14/S7B Draft Q&As available now on the ICH website

The ICH E14/S7B draft Q&A document on “Clinical and Nonclinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential” reached Step 2b of the ICH Process on 27 August 2020.

 

The ICH S11 introductory training presentation available now on the ICH website

The ICH S11 Guideline on Nonclinical Safety Testing in Support of Development of Paediatric Pharmaceuticals reached Step 4 of the ICH Process in April 2020.

 

INFARMED

Comunicado de Imprensa - Suspensão momentânea de vacina para COVID-19

De acordo com a informação pública, o laboratório farmacêutico AstraZeneca suspendeu momentaneamente os ensaios clínicos que decorrem a nível mundial para avaliar a segurança e a eficácia da sua vacina para a COVID-19.

 

Suspensão da comercialização e retirada do mercado das máscaras cirúrgicas, com marcação CE, do fabricante OrbitPlatform, Lda.

Foi identificada a colocação no mercado nacional e comercialização de máscaras cirúrgicas do tipo I com as referências MC10001, MC10001.1, MC10002, MC10003 e do tipo IIR com referências MC20001, MC20002 e MC20003, do fabricante OrbitPlatform, Lda. ostentando marcação CE indevida, por não existir evidência de cumprimento de todos os requisitos legais aplicáveis e pela documentação técnica se encontrar incompleta, nos termos previstos do Anexo VII do Decreto-Lei n.º 145/2009, de 17 de junho, na sua atual redação.

 

 

EFPIA European Federation of Pharmaceutical Industries and Associations

 

EFPIA statement on the European Regulatory Network Strategy to 2025

EFPIA welcomes the European medicines regulatory agencies network (EMRN) draft strategy to 2025 (EUNS 2025) and fully supports the establishment of an overarching strategic plan. EFPIA views the EUNS 2025 and the related EMA’s Regulatory Science Strategy to 2025 (RSS 2025) as essential to bringing the promising next wave of innovation to patients who live with the burden of unmet medical need.

 

A new start for European health systemsThe COVID-19 crisis has put the resilience and agility of European health systems to the test in an unprecedented way. The crisis has cast light on their strengths as well as weaknesses, in several cases a lack of preparedness, equipment and infrastructure to deal with an event of these proportions, but also great solidarity, inventiveness and resilience, not the least on part of the health workforce which has led the way in fighting the pandemic on the ground.

 

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