Regulatory News - December
EMA organises public meeting on COVID-19 vaccines on 11 December 2020.
EMA will organise a public meeting on 11 Dec 2020 to inform European citizens about the EU regulatory processes for the approval of COVID-19 vaccines and the Agency’s role in their development, evaluation, approval and safety monitoring. The COVID-19 pandemic is an unprecedented global crisis, with devastating health, social and economic impact. Safe and effective vaccines for COVID-19 are urgently needed to respond to this crisis and reduce its effects. Together with the European medicines regulatory network, EMA is supporting the development of COVID-19 vaccines and has taken steps to speed up the evaluation processes for these vaccines. The Agency and its partners are doing so while ensuring that the same high regulatory standards for quality, safety and efficacy are being applied to COVID-19 vaccines. The public meeting will inform citizens about EMA’s role in the pandemic and of EU regulatory procedures. It will also give the opportunity to the public and stakeholder groups to speak and share their needs, expectations and any concerns, that will be considered by EMA and the European medicines regulatory network in the decision-making process. The public meeting will be broadcast live and will be open to all citizens. In addition to the selected list of speakers, during the meeting there will be a mailbox open via EMA’s website for the public to make comments. The agenda and all information related to the event are available on the EMA website event page.
EMA PV plan for Covid-19 vaccines - Safety monitoring plan and guidance on risk management planning for COVID-19 vaccines.
The EMA has released a PV plan for Covid-19 vaccines. The document provides an overview of the activities the EU regulatory network (EMA and NCAs) will conduct once COVID-19 vaccines are authorised. The main objectives of the plan include:
Active collection of data on rare potential risks
Rapid detection, prioritisation, and assessment of emerging safety information derived from spontaneous reporting systems, observational studies, and other data sources
Prompt evaluation of the impact of detected safety issues on the benefit-risk balance of the vaccines, taking into account exposure and effectiveness data
Active surveillance of vulnerable populations, such as pregnant women and older vaccinees
Engagement and collaboration with stakeholders including vaccinees and healthcare professionals, marketing authorisation holders (MAHs) and international partners
Prompt and effective communication of new information arising from the above activities.
Importance of registration of COVID-19 related observational studies in the EU PAS Register – call for researchers. EMA’s stakeholders database communication:
“Dear colleagues, In these exceptional circumstances, many research groups in Europe and around the world are performing observational studies related to the utilisation and effects of drugs in relation to the Covid-19 pandemic. In order to support the sharing of information on performed or planned studies and increase the efficiency of research, ENCePP (European Network of Centres for Pharmacoepidemiology and Pharmacovigilance) and EMA (European Medicines Agency) strongly encourage all researchers to register their pharmacoepidemiological studies related to the Covid-19 pandemic in the EU PAS Register available on the ENCePP website through the following link: http://www.encepp.eu/encepp/studiesDatabase.jsp. Researchers are also encouraged to upload and make public their study protocols/results with a description of the data collected or planned to be collected in order to facilitate and speed-up the design of observational studies by others. When registering the studies, researchers should include the term “COVID-19” in their study title. This will facilitate the retrieval of studies related to the Covid-19 pandemic when typing this term in the field “Title of Study” of the database’s search function. Note: The important added value of registering studies in the EU PAS Register of course also applies to observational research non-related to Covid-19. To better support you, we will organize a webinar early 2021 for ENCEPP members where instructions on the registration procedure will be illustrated in detail. We would be grateful if you could apply and forward this communication to all relevant stakeholders.”
COVID-19 updates in the EMA’s newsletter “Human Medicine Highlights” (November 2020).
Check out the EMA’s newsletter “Human Medicine Highlights” issued in November 2020: on page 6, the following updates are available as hyperlinks:
COVID-19 • EMA starts first rolling review of a COVID-19 vaccine in the EU • EMA starts second rolling review of a COVID-19 vaccine • Extra transparency measures for COVID-19 vaccines and therapeutics • EU regulators fully uphold transparency and independence standards for COVID-19 treatments and vaccines • Strengthening global collaboration on COVID-19 real -world evidence and observational studies • Reply to the European Ombudsman’s letter concerning transparency and independence of the work of the European Medicines Agency in supporting the development and evaluation of COVID-19 medicines
Ulipristal acetate for uterine fibroids: EMA recommends restricting use
EMA’s human medicines committee (CHMP) has recommended restricting use of medicines containing ulipristal acetate 5 mg (Esmya and generic medicines) as a result of cases of serious liver injury. The medicines can now only be used to treat uterine fibroids in premenopausal women for whom surgical procedures (including uterine fibroid embolisation) are not appropriate or have not worked. The medicines must not be used for controlling symptoms of uterine fibroids while awaiting surgical treatment. Information on the risk of liver failure (requiring liver transplantation in some cases) will be added to the summary of product characteristics and the package leaflets for ulipristal acetate 5 mg medicines as well as in educational material for doctors and cards for patients. The CHMP recommendation will now be forwarded to the European Commission for its decision. The use of 5-mg ulipristal acetate medicines for uterine fibroids had been suspended as a precaution while awaiting the outcome of this review. For more information, please click here.