What is the difference between CEP and Asmf?

Active Substance Master File (ASMF) or Drug master file (DMF) or CEP is the set of series of information for an Active Pharmaceutical Ingredient (API) or Drug substance brought together in CTD format as per regulatory requirements.

What is an Asmf?

The main objective of the Active Substance Master File (ASMF) procedure, formerly known as the European Drug Master File (EDMF) procedure, is to allow valuable confidential intellectual property or ‘know-how’ of the manufacturer of the active substance (ASM) to be protected, while at the same time allowing the …

What is Asmf worksharing?

In January 2017 the ASMF worksharing procedure was established as a standard (voluntary) process. The ASMF worksharing procedure is basically a method to share and use ASMF assessment reports for the same ASMF version mutually by the national competent authorities/EMA.

How many modules are there in CTD?

five modules
The CTD is organized into five modules. Module 1 is region specific. Modules 2, 3, 4, and 5 are intended to be common for all regions. Conformance with this guidance should ensure that Modules 2 through 5 are provided in a format acceptable to the regulatory authorities.

What does DMF stand for in pharmaceuticals?

I. INTRODUCTION. A Drug Master File (DMF) is a submission to the Food and Drug Administration (FDA) that may be used to provide confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs.

What is DMF Loa?

Letter of Authorization (LOA) the information in the DMF by reference. The holder MUST submit an LOA (2 copies for paper) to the DMF THEN send a copy to the APPLICANT APPLICANT submits copy of LOA in their Application. ONLY mechanism to trigger complete technical review of the DMF.

What is a drug master file FDA?

Drug master files (DMFs) are submissions to FDA used to provide confidential, detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of human drug products. They: Allow parties to reference material without disclosing DMF contents to those parties.

How is an EMA application procedure number attributed?

4.7 How is an EMA application/procedure number attributed? On receipt of a submission, details of the product/procedure are entered into a tracking database which attributes product and procedure numbers.

What is Module 4 in CTD format?

Module 4: Safety (nonclinical study reports) Module 4 describes the format and organisation of the nonclinical (pharmaco-toxicological) data relevant to the application. This module is an EU CTD document adopted in Australia.