This meeting between European Medicines Agency (EMA) and Vaccines Europe is organised in the context of the EMA annual bilateral meetings with industry stakeholder organisations. The purpose of the meeting is to exchange views and...
Guidance information for people who wish to apply to release a vaccine or a blood product to market in the UK. Read the updated news from Medicines and Healthcare products Regulatory Agency published on 25 September...
The World Health Organization (WHO) has published a new report to guide vaccine developers when creating innovative vaccines to treat human papillomavirus (HPV) infections in adults. […] The WHO Preferred Product Characteristics for Therapeutic HPV...
The EMA issued a Concept paper on the revision of the COVID-19 vaccines guidance documents. During the COVID-19 pandemic, the EMA Emergency Task Force (ETF) issued two guidance documents on regulatory requirements for COVID-19 vaccines....
This Addendum to the guideline provides guidance on clinical studies to be conducted in immunocompromised individuals before or after initial marketing authorization of vaccines in order to support recommendations for use in the Product Information....
The European Medicines Regulatory Network (EMRN) has been at the forefront of the fight against COVID-19 with its crucial role in the evaluation and monitoring of medicines, including vaccines. A joint report issued by the...
Today, the European Patent Office (EPO) published a new patent insight report on mRNA technologies. The report summarises the results of patent analyses in the field of mRNA-based vaccines, which helped save millions of lives...
The Vaccine Monitoring Platform (VMP) is a collaboration between the European Medicines Agency (EMA) and the European Centre for Disease Prevention and Control (ECDC) aiming to generate real-word evidence (RWE) on the safety and effectiveness...
The study on the coherence, complementarity and continued relevance of actions in the Council Recommendation on strengthened cooperation against vaccine-preventable diseases in view of possible similar policy initiatives in the future’ aims to support the...
The Guideline for Pandemic COVID-19 vaccine (mRNA), in force since 12 November 2020, has been updated to accommodate bivalent mRNA COVID-19 vaccines. See the relevant EDQM relevant webpage to access the guideline.
