Skip to main content

European Medicines Agency : no longer ‘the EMEA’ – and not ‘the EMA’ either

BayBiotech.NET

European Medicines Agency is in the process of changing its acronym from EMEA to EMA based on the feedback from the stakeholders over the past years who had questioned the existence of the second ‘e’ in the acronym which does not accurately reflect the full name. In addition, since EMEA is most frequently used in the business community to mean Europe, Middle East and Africa , European Medicine Agency has decided not to use EMEA to avoid the confusions.

Since the inception, the adaptability of the acronym EMA is still to be validated and hence the agency decides to be using its full name as European Medicines Agency or the ‘Agency’ for short in the communications with e-mail ids being exceptions where ema will be used.

The press release from EMEA has the details of all the recent changes that the Agency has undergone and is in the process of implementaion.

Rest to follow…

Comments

Post a Comment

Popular posts from this blog

Group C (Treatment IND) Drugs

BayBiotech.NET Since 1976, National Cancer Institute (NCI) in agreement with FDA has established the Group C classification system to allow access to certain drugs for the cancer patients specifically falling under a category that adequate alternative therapy or if the available alternative therapy has significant toxic effects. Each Group C drug protocol specifies patient eligibility and drug use information. Group C drugs are provided only to properly trained physicians who have registered themselves with NCI using a special form to assure that their patient qualifies under guidelines - or protocols - for the drug. Physicians using drugs under Group C have no reporting requirements to the NCI other than the obligation to report adverse drug reactions. Group C drugs are provided free of charge, and the Centers for Medicare and Medicaid Services provides coverage for care associated with Group C therapy. Making Group C drugs available to the critically ill patients not only provi...
Post a Comment
Read more

Good Machine Learning Practices

BayBiotech.NET A joint effort by FDA,  United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) and Health Canada have developed guiding principles to help promote utilization of medical devices that are safe and effective and utilize artiificial intelligence and machine learning. To find out more details check out the link here!
Post a Comment
Read more

Harmonization by Doing (HBD): Japan & U.S. Collaboration

BayBiotech.NET HBD is an international cooperative effort by Japan and US for regulatory convergence for Medical Devices. The efforts are focused on to develop global clinical trials and address regulatory barriers for timely device approvals. To address the needs for additional evaluation, the HBD initiative is a pilot project launched jointly by FDA and MHLW-PMDA for the premarket review of device cardiovascular technology. Instead of taking a theoretical approach to harmonization, HBD is focused on Proof of concept by utilizing parallel development, application submissions and review of actual medical device projects. HBD Study intends to collect and analyze regulatory submission data from multiple applications in the U.S. and Japan. The purpose of the study is to further understand differences that may exist with format and content, to define best practices and to improve globally harmonized processes. To read more about the HBD program, follow the link: http://www.fda.gov/M...
Post a Comment
Read more