The role of Pharmaceutical Regulatory Agencies in ensuring the safety of Drug Products

Regulatory agencies are independent governmental bodies established by the legislature to perform and impose specific laws in a specific field of activity. These agencies create, monitor and implement laws and ensure that activities are performed in regulatory compliance.


Pharmaceutical regulatory agencies are the regulatory agencies that establish and implement specific laws for pharmaceutical product manufacturing, approval, clinical trials, and other pharmaceutical-related activities. The main objective of pharmaceutical regulatory agencies is to ensure the safety, efficacy, and quality of the drug. Every country has their own pharmaceutical regulatory authorities. Some of the various regulatory agencies are the following:

•           Central Drug Standard Control Organization (CDSCO) – India

•           European Medicines Agency (EMEA) - Europe

•           Food and Drug Administration (FDA) - USA

•           Pharmaceutical and Medical Device Agency (PMDA) - Japan

•           Health Canada - Canada

•           Medicines and Healthcare Products Regulatory Agency (MHRA) – UK

So, these regulatory agencies play a vital role in evaluating drug safety. Drug safety is a critical step and is most important aspect in the drug development process which means a drug that produces pharmacological action should be safe and effective and does not produce any harmful effects to the patient or consumers or its benefit are more than the risk associated with the drug.

These regulatory agencies establish various laws, guidelines, and standard sets of rules related to drug safety. The various pharmaceutical industries, CROs, and other organizations involved in the drug development process must follow these standard rules, guidelines and they must be in regulatory compliance.

Drug safety is evaluated at every step in the drug development process and till the drug is available in the market. Drug safety is initially evaluated at the pre-clinical studies in the pre-clinical studies the drug safety is evaluated on the animals and various in vitro and in vivo test are performed to assess the safety of the drug, after providing the relevant pre-clinical studies data and files for IND application to the regulatory agency. The regulatory agency will evaluate the collected data and after evaluation decides whether to approve or not approve the IND application.

 After getting IND approval drug safety is evaluated in various phases of clinical trials, in these phases drug is administered to a group of patients and evaluates the safety and efficacy of the investigational drug and collects the required data for the drug approval process, after completion of clinical trials, companies will file an NDA application for marketing the drug in the country to which filling the application. NDA application is evaluated by regulatory agencies and regulatory agency will decide whether the drug should be marketed or not. The collected data should be as per the regulatory requirements, and must be true and accurate. The clinical and pre-clinical studies must be performed in regulatory compliance if they are found not in compliance then the drug approval application is rejected, penalties and fines are also charged to the companies or organization. And when the drug is marketed in the market the drug safety is evaluated by the pharmacovigilance department and the safety data and ADR are reported to the pharmacovigilance department or complaints registered to the companies this information is provided to the regulatory agency of the country in which the drug is marketed and take required action according to the reported ADR

There are various third-party or outsourcing companies that provide regulatory services to pharmaceutical companies but some companies have their own regulatory affairs department. These third-party or outsourcing companies will help in providing strategies and ensuring the company activities and functions are in regulatory compliance, also performing the regulatory works and filling approval and permissions.

In conclusion the pharmaceutical regulatory agencies are the solely responsible for the approval, manufacture and available in the market. Regulatory agency is the independent body which protects the human from harmful pharmaceutical products and ensures the consumer will get safe and effective drug.

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