Importance of Regulations in Pharmaceutical Industry

Pranjul shrivastava

Assistant Professor,Faculty of Pharmacy, Kalinga University

Pranjul.shrivastava@kalingauniversity.ac.in

A regulatory framework for medications should ensure that patients have timely access to efficient treatments, safeguard patient safety, and promote the development of novel therapeutic options. In order to ensure that the system is effective, transparent, and resilient and that its choices are supported by reliable scientific evidence, patients, the medical community, the government, and the pharmaceutical sector have a shared interest. The Medicines and Healthcare Products Regulatory Agency is the governing authority in the United Kingdom.

Regulatory affairs serve as the pharmaceutical industry’s safety net. They serve as the link between pharmaceutical firms, governing bodies, and consumers and defend the public’s health. They provide pharmaceutical businesses with fact-based, strategic guidance on the legal and scientific requirements necessary to assure the production of safe and effective medicines.

Drug production is a very time-consuming process that involves regulatory affairs professionals at every level, from basic development through commercialization. In fact, without the engagement of Regulatory Affairs, it would be impossible to secure approval for the initial research and drug development.

Experts in regulatory affairs are involved throughout the entire development process, even after the drug has been approved and put on the market. They have a rare blend of managerial and scientific abilities to complete a task that is crucial for the organization’s commercial success. The highest degree of strategic and technical guidance is given by the regulatory affairs division. They significantly contribute towards the drug development.

Reference

1. National Audit Office. Safety, quality, efficacy: regulating medicines in the UK. London: Stationery Office, 2003.
2. Committee on Safety of Medicines. Report of the CSM expert working group on the safety of selective serotonin reuptake inhibitor antidepressants. London: Stationery Office, 2005.
3. Medicines and Healthcare Products Regulatory Agency. Review of the evidence on long term safety of hormone replacement therapy. Current Problems in Pharmacovigilance2004;30: 4-7.