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  • Novidades 10 de agosto 2020 0

ECA - EUROPEAN COMPLIANCE ACADEMY

 

GMP Question and Answer Guide „GMP Advisor“ – New Version 2.0. – March 2020
Searching for concrete answers to GMP questions is a time-consuming activity. The document is intended to provide a single source of information. We have summarized GMP questions and answers from regulators around the world. Version 2.0. was released in March 2020 (…).

ASMF: Two API Manufacturing Sites Listed - Only One to Be Registered?

The Q&A document "QP Declaration" including updates can be found on the HMA (Heads of Medicines Agencies) website in the section "CMDh". General information on "How to submit an Active Substance Master File?" can be found here.

 

ASMF: Two API Manufacturing Sites Listed - Only One to Be Registered?

This is now also possible for ASMFs and the procedure is clearly described in the updated Q&A document of the CMDh.

 

Inspectorates start again with domestic Inspections

Inspectorates are restarting domestic on-site inspections. Announcements were made by FDA and MHRA.

 

FDA Warning Letter to Homeopathic Product Manufacturers due to Quality Issues

The U.S. Food and Drug Administration (FDA) has issued a warning letter to Washington Homeopathic Products, Inc. due to specific violations of CGMP regulations. These violations include failure to establish an adequate quality control unit, failure to conduct at least one test to verify the identity of each component of a drug product, and failure to establish and document the accuracy, sensitivity, specificity, and reproducibility of test methods.

 

ISO TR 20416 on Post-Market Surveillance published

The new ISO Technical Report on Post-Market Surveillance for medical devices has been published this month. It shall help to implement a Post-Market Surveillance Process according to (EU) MDR 2017 / 745.

 

ISO TR 24971 Guidance on Risk Management published

The new ISO TR ISO/TR 24971:2020 Guidance on Risk Management for medical devices has been published last month. This Technical Report provides additional guidance on how to implement a Risk Management System according to ISO 14971.

 

EDQM 

 

Ph. Eur. Supplement 10.3: CEP holders are invited to update their applications

Supplement 10.3 of the Ph. Eur is now available. CEP holders are invited to update their applications according to the revised monographs that will be implemented on the 1st of January 2021, and to follow the instructions given in the document.

NEW WEBINAR: Implementation of the ICH Q3D Guideline on Elemental Impurities in the European Pharmacopoeia and the Certification Procedure
Supplement 10.3 of the Ph. Eur is now available. CEP holders are invited to update their applications according to the revised monographs that will be implemented on the 1st of January 2021, and to follow the instructions given in the document.



EMA - EUROPEAN MEDICINES AGENCY

 

PRAC recommendation on signal: New product information wording: extracts from PRAC recommendations on signals adopted at the 6-9 July 2020 PRAC (new)

 

PRAC recommendation on signal: PRAC recommendations on signals adopted at the 6-9 July 2020 PRAC meeting (new)

 

Availability of medicines (updated)

In July 2019, EMA and HMA published guidance for marketing authorisation holders on detecting and reporting medicine shortages: Guidance on detection and notification of shortages of medicinal products for Marketing Authorisation Holders (MAHs) in the Union (EEA).

Update: EMA and HMA intend to launch a pilot project on implementing the guidance, which is delayed to the first quarter of 2021 due to the COVID-19 pandemic. EMA and HMA will provide further information for marketing authorisation holders before starting the pilot.

 

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 20-23 July 2020

EMA’s human medicines committee (CHMP) recommended eleven medicines for approval at its July 2020 meeting, including a medicine for use in countries outside the European Union.

 

FDA

 

Coronavirus (COVID-19) Update: Daily Roundup July 28, 2020

The U.S. Food and Drug Administration announced the actions taken in its ongoing response effort to the COVID-19 pandemic.



HMA - CMDH

 

Information on nitrosamines for marketing authorisation holders

Questions and answers for marketing authorisation holders/applicants on the CHMP Opinion for the Article 5(3) of Regulation (EC) No 726/2004 referral on nitrosamine impurities in human medicinal products.

BREXIT. The United Kingdom submitted on 29 March 2017 the notification of its intention to withdraw from the Union pursuant to Article 50 of the Treaty on European Union.

This means that unless a ratified withdrawal agreement establishes another date, all Union primary and secondary law ceases to apply to the United Kingdom from the UK withdrawal date. The United Kingdom will then become a 'third country'.


NEW - Template for RMS Assessment Report on Similarity

UPDATE - RMS Day 70 Overview template

UPDATE - RMS Day 120 Overview template

UPDATE - PSUR summary assessment report for doxylamine hydrogen succinate, pyridoxine hydrochloride



INFARMED

Alterações aos termos de AIM - Procedimento Nacional - Perguntas frequentes

 

 

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