Tanzania Consults On East African Community Guidelines, Including For Biosimilars
Executive Summary
The Tanzanian drug regulator is holding a stakeholder workshop on Jan. 25 to discuss the adoption of various guidelines drafted by medicines experts within the East African Community network. On the list of documents to be discussed is a draft guideline on the registration of biosimilars.
You may also be interested in...
Plans For East African Drug Regulator Begin To Take Shape
A report by the European Medicines Agency and the regulators from the East African Community has outlined the possible shape of a regional regulator in east Africa.
EU Consults On What Constitutes Personal & Commercially Confidential Data In Marketing Applications
Based on their experience with dealing with requests for access to documents over the past 12 years, EU regulators have proposed updating their guideline that provides for a harmonized approach to protecting personal data and business secrets in marketing authorization applications.
Global Pharma Guidance Tracker – March 2024
Stay up to date on regulatory guidelines from around the world with the Pink Sheet's Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.