Requirements for Medicines Registration in the Americas. Washington, DC : PAHO, 2013. (Pan American Network on Drug Regulatory Harmonization - PANDRH, Technical Document n.10).
1. Pharmaceutical Services - legislation & jurisprudence.  2. Pharmacy Administration. 3. Legislation, Pharmacy. 4. Research Report.  5. Americas. I. Title.

ISBN 978-92-75-11757-6 

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This document comprises the requirements for the initial registration of medicines (marketing authorization) in the Americas, prepared by the Working Group on Medicines Registration of the Pan American Network on Drug Regulatory Harmonization (PANDRH). Its purpose is to provide requirements for establishing regulations and regulatory tools that will contribute to the harmonization process of medicines registration to ensuring the efficacy, quality and safety of medicines to be available in the countries of our Region.

National standards shall be established in keeping with each country's legislation, and whenever pertinent, appropriate changes will be made in order to adhere as much as possible to these requirements.

In keeping with the format found in other similar guidelines of the Pan American Network on Drug Regulatory Harmonization (PANDRH), this document consists of four (4) modules and two (2) annexes.
  • Module 1: Administrative and legal information.
  • Module 2: Quality information.
  • Module 3: Nonclinical reports.
  • Module 4: Clinical reports.
  • Annex 1: Summary of Product Characteristics (SPC).
  • Annex 2: Information on labelling and package inserts.

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