Having a strong drug safety and security program is very important for the foundation of national ethos worldwide. Pharmacovigilance, the concept of drug safety programs require strong links with the regulatory body to make sure those authorities are aware of the safety issues in daily practice. Regulators know that pharmacovigilance is a specialized area that plays a key role in the ongoing safety measures taken to protect medicinal products.
The New Age of Medicines
Medicines have to pass through 3 different hurdles before getting an approval from the national drug regulatory authority. Adequate evidence is needed to prove that the drug is effective, maintains quality standards, and is safe for the proposed purpose.
To get an approval, it is very important to ensure that the quality of drug is good and it is effective. Safety, however, is not the absolute factor as it can only be judged with respect to efficacy and judgment needed for regulators in choosing or deciding the acceptable safety limits.
Emphasis on Clinical Trials
In the recent years, the concept of clinical trials has increased substantially in developed as well as developing nations. Clinical trials in the U.S have doubled in a period of 8 years from 1990 to 1998. There are many conflicting thoughts and opinions, which have evolved over the years, thus creating potential differences.
The emerging trends, for drug regulators, have revealed some potential urgent challenges, specifically to ensure that patients’ health and rights are protected. While approving clinical trials, different regulatory bodies consider efficacy and safety of their subjects.
It is an accepted and well established fact that the process of drug safety evaluation happens in the approval phase. In any case, if vital innovations are lost, the responsibility of judgment rests with the regulators.
Careful and safety monitoring of drugs is not confined. However, it is very important during the introduction phase of generic medicines and while reviewing the safety profile of medicines already found in the market, where some new issues may have cropped up.
There are several aspects of drug safety that have been neglected till now. However, with these modern regulations have tried to address issues like drug interaction detection, environmental burden evaluation, assessment of inactive ingredients and its contribution to the safety profile of medicines, different systems to compare safety profiles of similar composition of drugs, and surveillance of adverse effects of medicines on human health due to animal residues found in medicines like hormones and antibiotics.
Drugs, medicines, biotechnology products, veterinary medicines, and genetically modified or derived medicinal products are all likely to fall under the vigilance of regulatory authorities. A proper collaboration with expertsmay be necessary to ensure safe and effective pharmacovigilance in the world.