EMA’s further step towards transparency Most regulatory agencies that are strongly committed to promoting safe use of medicines constantly strive to communicate with the public and stakeholders in an open and transparent manner. They put in the best efforts to convey information about the medicines and their use to the consumers in an easy and comprehensible form. Increased transparency and public access to information about medicinal products are high on the agenda of the European Medicines Agency (EMA). The EMA has put in place the European Risk Management Strategy (ERMS) which focuses on proactive conduct of pharmacovigilance in the European Union (EU) and lays out measures that allow for the early detection, assessment, minimization and communication of risks of medicinal products throughout their lifecycle.
Medical Regulatory Affairs Today
Human exposure to veterinary medicines
For the past decade the issue of human exposure to veterinary medicinal products (VMPs) has been a difficult issue for the industry to deal with. This has led to significant challenges for regulatory authorities with regards to the implementation of both wide ranging and specific guidelines.
Certifying the quality of an API
What is a CEP?
A Certificate of Suitability to the monographs of the European Pharmacopoeia (CEP) certifies that the quality of an active pharmaceutical ingredient (API) can be suitably controlled by the European Pharmacopoeia monograph, with additional tests dependant on the method of synthesis. The role of the CEP is to certify the compliance of a material with the requirements laid down in the relevant monograph. CEP’s were established in 1994 for pharmaceutical substances, and later for herbal drugs, and products with risk of TSE. CEP’s are recognised by the signatory parties of the convention on the elaboration of a European Pharmacopoeia i.e. all member states and the European Union. They are also recognised by other countries e.g. Canada, Australia, New Zealand, Tunisia and Morocco.
The current Clinical Trials Directive (CTD) 2001/20/EC was established in 2001 and has been very successful in terms of improving safety and the reliability of trial data. However it has also been widely criticised for decreasing the attractiveness of clinical trials within the European Union (EU). Since the implementation of Directive 2001/20/EC there has been a significant reduction in the number of clinical trials carried out in the EU. This decrease has largely been blamed on the increased administration costs introduced by the Directive and the delays in obtaining clinical trial authorisation.
The importance of communication and the scientific method
As the world continues to be modernized, more and more questions emerge, some of which may impact our daily lives. Finding responses to these sometimes “worthwhile” questions in most cases, requires careful research via a systematic and scientific approach. Research has seen the progression of issues such as government reforms, civil liberties, regulatory frameworks, technology, etc. that impact our livelihoods. The evolution of science and the advancement of key therapies also have their roots in research and development. Constant studies and the provisions of new treatments, new therapies and new cures, mean that medicines are now available for the management and diagnosis of even some of the rarest diseases, thereby, improving the quality of life of millions of patients worldwide. In spite of these ground-breaking efforts, clear and accurate reporting is essential. Like a skydiver without his / her parachute, the importance of medical writing in research should or must not be underestimated because research often painstakingly and meticulously performed can be tarnished with improper presentation.