Glossary of Clinical Terms

✅ The process of legally documenting and enlisting a product for its intended use with the designated bonafide regulatory authorities of a country or region is known as product registration. The designated bonafide authorities are usually under the Ministry of Health of the government of that state or country. Product registration ensures that a product fulfills the necessary safety, quality, and efficacy criteria before it can be sold or supplied in the market for the intended therapeutic indication approved by the regulatory authorities.

✅ The registration process varies based on the type of product and the country or region’s regulatory environment and requirements. In general, product registration entails the following important elements: documentation submission consisting of quality, evidence of efficacy and safety. This submission undergoes evaluation and review, compliance assessment. Based on the assessment of the submitted dossier, a product registration could be granted or rejected. Following product registration very often authorities ask the marketing authorization holder to undertake post-marketing surveillance study.

✅ The registration process for pharmaceutical products varies and each regulatory authority of a country has its own set of standards and procedures. Most countries require the quality module along with the details of preclinical investigations, and clinical trials in phases I, II, and III as a part of a new drug application (NDA) or marketing authorization application (MAA). In a few countries, Product Registration needs to be renewed every five years.