Welcome to our new website! If this is the first time you are logging in on the new site, you will need to reset your password. Please contact us at email@example.com if you need assistance.
Your membership opens the door to free learning resources on demand. Check out the Member Knowledge Center for free webcasts, publications and online courses.
This comprehensive resource covers product change evaluation, postmarket surveillance, audit/inspection compliance, and various other laws and regulations pertaining to maintaining a product on the market.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
Regulatory News | 26 February 2018 | By Michael Mezher
The European Medicines Agency (EMA) on Monday released its first biennial report on efforts to replace, reduce and refine the use of animals in research used to support the marketing authorization of drugs and biologics in the EU, referred to as the "3Rs."
Marketing authorization holders in the EU are required to integrate the 3Rs in addition to EU standards for animal welfare and treatment when developing, manufacturing or testing healthcare products.
"Although the ultimate aim is to replace the use of live animals in medicine testing, they continue to be necessary in some areas of medical research to protect human and animal health and the environment, until further scientific advancements enable the development of adequate alternatives," EMA writes.
The report is based on actions taken by the Committee for Medicinal Products for Veterinary Use (CVMP) and Committee for Medicinal Products for Human Use (CHMP) over the last two years to build on EMA's efforts to implement the 3Rs.
In 2010, EMA formed a Joint CHMP/CVMP Expert Group on 3Rs (JEG 3Rs) to provide input and recommendations to the agency on the use and testing of animals in the development of drugs and biologics.
By late 2016, after determining that the JEG 3Rs had met its mandate, the agency launched a new, smaller working group, the Joint CVMP/CHMP 3Rs Working Group (J3RsWG), focused on providing input on request to CVMP and CHMP, finalizing guidelines on the 3Rs and reviewing batch release tests for vaccines and biologics to ensure alignment with the principles.
Since its launch, the J3RsWG has contributed to the development of two guidelines and two reflection papers on 3Rs.
Two of those guidelines, covering regulatory acceptance of 3Rs testing approaches and recommendations for transferring quality control methods validated in collaborative trials to new laboratories in line with 3Rs principles, were adopted in 2017.
The two reflection papers, which outline the current regulatory testing requirements for medicinal products for either human or veterinary medicines, have gone through public consultation and are expected to be finalized in Q1 2018.
Looking ahead, EMA says the focus of the J3RsWG will focus on the finalization and adoption of additional guidelines and reflection papers, the evaluation of batch release testing for human and veterinary vaccines and biologics, implementation of Directive 2010/63/EU (including training for regulators) and to serve as a platform for EMA on other 3Rs related issues.
But EMA notes that challenges related to Brexit may impact implementation as the agency shifts its focus to "core-business activities" such as reviewing marketing authorization applications and overseeing postmarket safety surveillance.
"However, the 3Rs will continue to be addressed, not least through the continued endeavor of the working parties and committees to implement the 3Rs principles without putting public health and animal welfare at risk," EMA writes.