Two additional countries to benefit from EU-US mutual recognition agreement for inspections On 10 June 2019, Luxembourg and the Netherlands were included into the mutual recognition agreement between the European Union (EU) and the United States Food and Drug Administration (FDA). The FDA thus confirmed the capability of these two additional EU Member States to carry out good manufacturing practice (GMP) …
Quality Requirements for Drug-Device Combinations EMA/CHMP/QWP/BWP/259165/2019 dated 29th May 2019: https://www.ema.europa.eu/en/quality-requirements-drug-device-combinations). This outlines the dossier data requirements for drug-device combinations (DDCs). The consultation period for this draft runs until 31.08.2019. This is an important draft guideline. The types of DDCs within the scope of this guideline are medical devices that are integral to the medicinal product, co-packaged with the medicinal …
This is a call for data on the ingredients: Gold (nano), colloidal gold (nano), platinum (nano), colloidal platinum (nano), Copper (nano) and colloidal copper (nano) in the framework of Regulation (EC) 1223/2009. Period of consultation 11 June 2019 – 10 November 2019 The action proposed by the Commission is found on their website.
Consultation on the application of Analytical Quality by Design (AQbD) principles to pharmacopoeial standards for medicines
MHRA GMP symposium 2019 https://mhrainspectorate.blog.gov.uk/2019/06/04/the-2018-gmp-symposium/
Webcast Links posted for June 19-20, 2019 Circulatory System Devices Panel The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Circulatory System Devices Panel of the Medical Devices Advisory Committee. The general function of the committee is to provide advice and recommendations to the Agency on FDA’s regulatory issues. The meeting will be open …
FDA issues Draft Guidance for Industry on Development of Therapeutic Protein Biosimilars: Comparative Analytical Assessment and Other Quality Considerations FDA released Draft Guidance for Industry: “Development of Therapeutic Protein Biosimilars: Comparative Analytical Assessment and Other Quality Considerations”. This draft guidance describes the Agency’s recommendations for the design and evaluation of comparative analytical studies, including considerations for the development of a comparative …
Statement on FDA’s request for information on requiring fixed-quantity blister packaging for certain opioid pain medicines to help decrease unnecessary exposure to opioids The opioid tragedy has become one of the defining public health crises of modern times. As the rates of opioid addiction and overdose continue to grow, addressing the opioid crisis has taken on more urgency. For the …
Issued April (but of interest to publishing teams) Q&A Publishing ASMFs for eCTD
GMP – MUTUAL RECOGNITION AGREEMENT WITH THE USA EU Mutual Recognition agreements – see section on the USA. In transition until July 2019. Now 24 Member States are recognised to perform inspections on behalf of the FDA.https://www.ema.europa.eu/en/human-regulatory/research-development/compliance/good-manufacturing-practice/mutual-recognition-agreements-mra Update: Questions and answers on the impact of mutual recognition agreement between the European Union and the United States as of 30 April …