Before a Medicinal Product is brought on the market and sold to the patients, it has to be granted a marketing authorisation. The authorisation requires that the sponsors prove the efficacy, safety and quality of the new medicine. In order to do so, clinical trials are conducted in health volunteers or patients, depending on the product and on the stage of clinical study.
Globally, the requirements of health authorities are very strict. Today, clinical trials cannot be conducted without the participation of scientific experts and approvals from ethics committees and health authorities. Strict provisions apply, aiming at the protection of clinical trial participants as well as at the quality of the test results. The harmonization process and procedures under the International Conference on Harmonization (ICH) shall allow achieving greater harmonization related to clinical trials and ensure compliance with the regulatory requirements and applicable local laws and regulations. The goal is to have high quality standards worldwide for the size and design of a study as well as for the quality of the test results.
In European countries, the local laws apply, based on the EU Directive on clinical trials (2001/20/EC), on international standards of Good Clinical Practice (GCP) - a result of the Helsinki Declaration of the World Medical Association (WMA)-, and on the internationally harmonized recommendations of ICH. All clinical studies must be approved by ethical committees and the national health authorities.
However, any medicine may have unexpected and unwanted effects. Medicines are not products like others. It is exactly for that reason that clinical studies must be conducted progressively, stage to stage. Furthermore, clinical studies can only be started after a compound has survived rigorous pre-clinical development work, which involves laboratory testing (chemical/biological/pharmacological/toxicological) and often work on animals. Due to this preclinical research, adverse effects and risks of new substances can often be detected in time. Hundreds of compounds tested every year in laboratories will never reach the stage of human trials and will never be tested in humans.
Thus, all studies involving humans are conducted according to national and international laws, standards and strict ethical principles aiming at the proper performance of clinical trials, the protection of participants and good quality of the resulting data.
WHAT ARE EBE ACTIVITIES AROUND CLINICAL TRIALS
Because in the EU, all clinical studies must be approved by ethical committees and national health authorities, it is sometime difficult for our members, particularly SMEs to be aware of all national laws that apply. EBE members have put in place a platform where they can share their experiences and give advice on CT Applications.