Spring Intro 2023

28/03/2023

3.2.S.1- General information

S.1.1 Nomenclature (INN, chemical name, company code, CAS No.) S.1.2 Structure – New Chemical Entity (NCE) – structural formula, stereochemistry, molecular formula, molecular weight

S.1.3 General properties

– Physicochemical and other relevant properties

INN – International Nonproprietary Name CAS Number – Chemical Abstracts Service Number

The Organisation for Professionals in Regulatory Affairs

9

3.2.S.2 - Manufacture

• Name and address of all facilities involved in the manufacture of the drug substance, including contractors.

• The description of the manufacturing process represents the applicant’s commitment for the manufacture of the drug substance. The information should adequately describe the manufacturing process and in-process controls.

• The guideline contains separate advice for NCEs and Biotechnology products.

The Organisation for Professionals in Regulatory Affairs

10