The number of applications pending, refused and granted for the early access to medicines scheme (EAMS). these tables are updated regularly and can be found on the GOV.UK website here.
EMA is recommending that bacterial lysate medicines authorised for respiratory conditions should only be used for the prevention of recurrent respiratory infections, with the exception of pneumonia. This follows a review that concluded that there are no robust data showing that these medicines are effective at treating existing respiratory infections, or for the prevention of pneumonia, therefore they should not …
The EDQM has revised the following documents to reflect current practice and clarify a couple of items: Terms of reference Code of Practice for the Certification procedure
On 26 June 2019, Germany was included into the mutual recognition agreement between the European Union and the United States Food and Drug Administration (FDA). The FDA thus confirmed the capability of this additional EU Member State to carry out good manufacturing practice (GMP) inspections at a level equivalent to the US. The agreement mutually recognises inspections of manufacturing sites …
Term and preterm neonates represent the most vulnerable subgroup of the paediatric population with the highest rate of unauthorised or off-label used medicines across the entire paediatric population. The Guideline on the investigation of medicinal products in the term and preterm neonates was prepared during the period from 2007 to 2009 and came into effect in 2010 (EMEA/536810/2008). Considerable experience …
A new post, “How the implementation of Safety Features progresses 5 months in” has just been published on the MHRA Inspectorate blog. The definition of a falsified medicine and how to check that your systems comply Read the new post: https://mhrainspectorate.blog.gov.uk/2019/07/05/how-the-implementation-of-safety-features-progresses-5-months-in/
· 7/1/2019 – Drug Abuse and Dependence Section of Labeling for Human Prescription Drug and Biological Products — Content and Format Guidance for Industry · 7/1/2019 – Instructions for Use — Patient Labeling for Human Prescription Drug and Biological Products and Drug-Device and Biologic-Device Combination Products — Content and Format Guidance for Industry
The European Union task force set up to address problems with medicines supply has published two documents today: guidance for marketing authorisation holders on reporting of shortages in the EU good practice guidance for communication to the public on medicines’ availability issues The task force was established by EU regulators to better address potential problems with medicines’ supply and to …
FDA Announces New Qualified Health Claims for EPA and DHA Omega-3 Consumption and the Risk of Hypertension and Coronary Heart Disease The U.S. Food and Drug Administration announced today that it does not intend to object to the use of certain qualified health claims stating that consuming eicosapentaenoic acid (EPA) and docosahexaenoic (DHA) omega-3 fatty acids in food or dietary …