by Naveen kumar | Jun 6, 2024
The Common technical document has 5 modules and is a format set by ICH for assembling the quality, safety, and efficacy information in a common format. The CTD document was introduced to streamline the dossier submission process as the earlier process was not uniform...
by Naveen kumar | Jun 5, 2024
In this article, you are going to learn about the marketing authorization process in the EU region. European Medicines Agency (EMA) is the key regulator for regulating and monitoring medicinal products in the European Union. It has some expert committees which provide...
by Naveen kumar | Jun 2, 2024
How orphan drug designation is given in Japan In the previous articles we have studied orphan drugs and now we are going to learn about how orphan drug designation is given in Japan, we are going to discuss how and what are the laws guiding orphan drug designation in...
by Naveen kumar | May 24, 2024
Drug Regulatory Authorities of Different Countries Drug regulatory authorities play a vital role in enabling the safety, efficacy, and quality of medicine we take. These authorities involve in overseeing the development, testing, approval, and monitoring of drugs...
by Naveen kumar | May 5, 2024
Active Substance Master File also known as European Drug Master File allows the protection of confidential information regarding the ” know-how of the active substance manufacturer”. While protecting the intellectual property information ASMF equips the...
