Documents / Reports / Submissions generated in Regulatory Affairs Department

The different types of Documents / Reports / Submissions generated in Regulatory Affairs Department are as follows.

1. USDMFs
2. CEPs / COS
3. ASMFs / EDMFs
4. Regional DMFs
5. Technical Packages
6. Amendments
7. Annual Updates
8. Revision / Renewal of CEPs.

1.0 USDMFs:

1.1 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.

1.2 The submission of a DMF is not required by law or FDA regulation. A DMF is submitted solely at the discretion of the holder. The information contained in the DMF may be used to support an Investigational New Drug Application (IND), a New Drug Application (NDA), an Abbreviated New Drug Application (ANDA), another DMF, an Export Application, or amendments and supplements to any of these.

1.3 A DMF is NOT a substitute for an IND, NDA, ANDA, or Export Application. It is not approved or disapproved. Technical contents of a DMF are reviewed only in connection with the review of an IND, NDA, ANDA, or an Export Application.

1.4 There are five types of DMF applicable for the below mentioned submissions.

Type I: Manufacturing Site, Facilities, Operating Procedures, and Personnel
Type II: Drug Substance, Drug Substance Intermediate, and Material Used in Their Preparation, or Drug Product
Type III: Packaging Material
Type IV: Excipient, Colorant, Flavor, Essence, or Material Used in Their Preparation
Type V: FDA Accepted Reference Information
1.5 Type II Drug Master File is the only scope of [Bulk Drugs & Intermediates Division].
1.6 For further information regarding USDMFs, reference to the USFDA website for the following link shall be accessed http://www.fda.gov/cder/guidance/dmf.htm.

2.0 CEPs / COS:

2.1 CEP stands for Certification of suitability of European Pharmacopoeia monographs. COS (“Certificate of Suitability”) means the same and, even if often used, is not the official acronym.

2.2 The role of the CEP is to demonstrate that the purity of a given substance produced by a given manufacturer is suitably controlled by the relevant monograph(s) of the European Pharmacopoeia. By demonstrating that they have been granted a CEP for their substance, suppliers of raw materials can prove this suitability to their pharmaceutical industry clients and/or the licensing authorities.

2.3 The application dossiers shall be prepared according to the CTD (Common Technical Document) format with observance to the current version of the concerned SOP.

2.4 A copy of a CEP is then sufficient in a marketing application dossier to replace the documents related to the drug substance or excipient in Common Technical Document in the Rules Governing Medicinal Products in EU (NTA, Vol.2 B-CTD module 3.2.S).

2.5 Legal Status:
Under the official procedure described in Resolution AP-CSP (07) 1 and Directives 2001/83/EC, 2001/82/EC and 2003/63/EC as amended of the European Union, manufacturers or suppliers concerning the respective product manufacturing can apply for
· the evaluation of the suitability of the monograph for the control of the chemical purity and microbiological quality of their substance; or,
· the evaluation of the reduction of TSE risk according to the general monograph; or,
· both of the above; or,
· the evaluation of the suitability of the monograph for the control of herbal drugs and herbal drugs preparations.
This procedure is aimed at facilitating and simplifying exchanges between the partners to ensure that the quality of substances is guaranteed and that these substances comply with the European Pharmacopoeia and therefore the requirements of EU directives for medicines.

2.6 Validity of a CEP:
The Certificate of suitability is valid for five years from the date when the original certificate was granted.

3.0 ASMFs / EDMFs

3.1 Active Substance Master File (ASMF) commonly known as the European Drug Master File (EDMF) is a submission made to European Competent Authorities and / or EMEAin support of Marketing Authorization Application [MAA] or Marketing Authorization Variation [MAV] of a medicinal product.

3.2 ASMF / EDMF shall be prepared in CTD format. The scientific information in the EDMF should be physically divided into two separate parts, namely the Applicants Part (AP) and the Restricted Part (RP). The AP contains the information that the EDMF holder regards as non-confidential to the Applicant / MA holder, whereas the RP contains the information that the EDMF holder regards as confidential.

3.3 In addition to the AP and RP, the EDMF should contain a table of contents, and a separate summary (QOS) for the AP and the RP.
3.4 Information pertaining to ASMF / EDMF content and for the submission procedure shall be observed from the current version of concerned SOP.

4.0 Regional DMFs

4.1 The Drug Master Files which are generated for the submission in the regions other than USA and Europe are covered under Regional DMFs.

4.2 As per the market requirements these DMFs are generated for the following countries:
1. Canada
2. Turkey
3. Brazil
4. Korea
5. South Africa
6. Australia
7. Syria
4.3 Regional guidelines of the respective countries shall be followed for generation and submission of the Regional Drug Master Files.

5.0 Technical Packages

5.1 Technical Packages are the documents prepared in order to provide precise information of the drug substance necessitated by customer for formulation development.
5.2 The basic information of the Technical packages includes Chemical Reaction Scheme, Characterisation, Specification and Method of analysis, Typical Certificate of Analysis, Stability data and Material safety data.

6.0 Amendments

6.1 A report of a change or addition of technical or administrative information to original submission to FDA; that is not covered in the purview of annual update. Basically categorized under;
- any change or addition to the technical information
- any change in authorization related to specific customers
- any change in holder name or ownership of the DMF or a change in agent name or address
6.2 The information pertaining to the submission of amendment shall be accessed from the current version of concerned SOP.

7.0 Annual Update

An annual report shall be prepared and submitted on the anniversary date of the original submission and shall also identify all changes and additional information incorporated into the DMF since the previous annual report. If the subject matter of the DMF is unchanged, a statement shall be provided stating that the subject matter of the DMF is current.

8.0 Revision / Renewal of CEPs

8.1 Revisions:

Type of submission through which the holder of a Certificate of suitability shall inform the EDQM of any change in the information included in the certification dossier by sending an application form and all necessary documents demonstrating that the conditions laid down in the present guideline are met.

8.2 Renewals:
The Certificate of suitability is valid for five years from the date when the original certificate was granted. Regardless of any revisions treated in the meantime, the holder of a Certificate of suitability shall ask for the renewal of the Certificate of suitability six months prior to expiry date by providing an update of the certification dossier.
8.3 The detailed information pertaining to the Revision / Renewal of CEP shall be observed from the current version of the concerned SOP.

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