Pharma GMP News of the Week: 26-December-2021

Period: December 19, 2021 to December 25, 2021

For the first time, EMA has issued a list of regulatory science topics that need further research to improve medicine development and evaluation to enable access to innovative medicines for patients.

Date of news :December 15, 2021

According to the news, “EMA has identified around one hundred specific topics in the Regulatory Science Research Needs list. These topics, and the initiative itself, emerged from the stakeholder consultations which underpinned the development of the Regulatory Science Strategy to 2025”.

The topics are divided in the following four categories:

“(i) Integration of science and technology in medicines development, (ii) Collaborative evidence generation to improve the scientific quality of evaluations, (iii) Patient-centred access to medicines in partnership with healthcare systems, and (iv) Emerging health threats and availability/ therapeutic challenges”.

Source: https://www.ema.europa.eu/en/news/ema-launches-regulatory-science-research-needs-initiative

Download: https://www.ema.europa.eu/en/documents/other/regulatory-science-research-needs_en.pdf

According to the Press release by European Commission on EU-UK relations, “Commission delivers on promise to ensure continued supply of medicines to Northern Ireland, as well as Cyprus, Ireland and Malta”

Date of press release: December 17, 2021

As per the press release “The Commission has put forward proposals to ensure the continued long-term supply of medicines from Great Britain to Northern Ireland and to address outstanding supply concerns in Cyprus, Ireland and Malta. In the context of the Protocol on Ireland/ Northern Ireland, this means that the same medicines will continue to be available in Northern Ireland at the same time as in the rest of the United Kingdom, while specific conditions ensure that UK-authorised medicines do not enter the Single Market”.

Source: https://ec.europa.eu/commission/presscorner/detail/en/ip_21_6911

Download: https://ec.europa.eu/commission/presscorner/api/files/document/print/en/ip_21_6911/IP_21_6911_EN.pdf

FDA has publishes draft guideline on “Digital Health Technologies for Remote Data Acquisition in Clinical Investigations”

Date of release: December 22, 2021

According the FDA, “guidance provides recommendations to sponsors, investigators, and other stakeholders on the use of digital health technologies (DHTs) to acquire data remotely from participants in clinical investigations evaluating medical products. DHTs may take the form of hardware and/or software and may be used to gather health-related information from study participants and transmit that information to study investigators and/or other authorized parties to evaluate the safety and effectiveness of medical products”.

Source: https://www.fda.gov

Download: https://www.fda.gov/media/155022/download

MHRA has updated guidance for Update to post-Brexit protocols

MHRA webpage for “New guidance and information for industry from the MHRA” showing guideline updates from Decembers 2021.

Date of news: December 2021

Source: https://www.gov.uk/government/collections/new-guidance-and-information-for-industry-from-the-mhra

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