4. Dmf
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U.S. Drug Master Files - A Primer Types, Purposes and Pitfalls
New England Biomedical Research, Inc.
1
Master Files Are Used To: •
•
Submit confidential information to FDA (information that you don’t want your customer to know, but which he needs for an FDA approval) Submit information known to you that would otherwise have to be included repeatedly in other applications (but this may not be a good practice)
New England Biomedical Research, Inc.
2
Master Files are Used To (cont.): •
•
Insert information into “review” documents by reference. “Review” documents include: NDA’s, NDA Amendments or Supplements ; CTDs and related documents: IND’s or IND Amendments ; ANDA’s, ANDA Amendments or Supplements ; Another DMF (rarely)
New England Biomedical Research, Inc.
3
Master Files are Not: • • •
A substitute for an IND, NDA, CTD, or ANDA Approved or Disapproved as a stand alone document Reviewed by FDA, ever, except in connection with the document in which they are included by reference
New England Biomedical Research, Inc.
4
Types of Drug Master Files • • • • •
Type I - Facilities, personnel, procedures (no longer applicable) Type II - Drug Substance, a substance intermediate or a Drug Product Type III - Packaging Material Type IV - Excipient, Color, Flavor, Essence Type V - Other New England Biomedical Research, Inc.
5
Type I DMF - Facility •
No longer applicable
New England Biomedical Research, Inc.
6
Type II DMF - Drug Substance • •
One per DMF Follow: – “Guideline for Submitting Supporting Documentation in Drug Applications for the Manufacture of Drug Substances” – “Guideline for the Format and Content of the Chemistry, Manufacturing, and Control Section of an Application” – Other guidelines may also apply
New England Biomedical Research, Inc.
7
Type II DMF - Drug Product • •
May need DMF in some cases Follow: – “Guideline for the Format and Content of the Chemistry, Manufacturing, and Control Section of an Application” – “Guideline for Submitting Documentation for the Manufacture and Control of Drug Products” – “Guideline for Submitting Samples and Analytical Data for Methods Validation” – Other guidelines may also apply
New England Biomedical Research, Inc.
8
Type III DMF-Packaging Materials •
•
• •
•
Identify Intended Uses, Components, Composition, Method of Manufacture and Controls for the Packaging Item Identify suppliers of components and controls on receipt of these-obtain a right of reference to their DMF if necessary Enclose Toxicology if required Follow “Guideline for Submitting Documentation for Packaging of Human Drugs and Biologics” Other guidelines may also apply New England Biomedical Research, Inc.
9
Type IV DMF Excipient/Color/Flavor, Etc. •
• •
•
Characterize by method of manufacture, specifications and test methods Include Toxicology if necessary Sources of release tests, Specs. and Safety may be compendial or regulations : Colors-21CFR Part 20-82 ;Food Additives Direct and Indirect-21CFR Parts 170-178; Food Substances-21CFR Parts 181-186 If Novel excipient, follow guidelines for characterization and qualification
New England Biomedical Research, Inc.
10
Type V DMF - Other •
Do not submit without pre clearance from FDA, except – DMFs to describe sterile product manufacturing plants may be filed as Type V DMFs. DMFs. It is not necessary to request prior clearance from FDA before filing such DMFs. DMFs. See Guidance for Industry for the Submission Documentation for Sterilization Process Validation in Applications for Human and Veterinary Drug Products. Products. – Similarly DMFs to describe contract facilities for the manufacture of biotech products may be filed as Type V Master Files without prior clearance from FDA. See Draft Guidance for Industry: Submitting Type V Drug Master Files to the Center for Biologics Evaluation and Research New England Biomedical Research, Inc.
11
General Notes • Type II, III and IV DMF’s require commitment that Environmental Laws will be complied with – If Environmental Assessment needed see 21CFR Part 25 and New Environmental Assessment Guidelines
• If Stability Data Needed, see ICH Guidelines and “Guideline for Submitting Documentation for Stability of Human Drugs and Biologics • Submit in Duplicate • Number Volumes 1 of 3, 2 of 3, etc.
New England Biomedical Research, Inc.
12
General Notes (cont.) • • •
Use 8 1/2 x 11 inch paper Large Drawings must be folded and mounted - no plastic inserts Address to – Food and Drug Administration Center for Drug Evaluation and Research Central Document Room 5901-B Ammendale Road Beltsville MD 20705-1266
New England Biomedical Research, Inc.
13
Authorization Letter • •
•
• •
Holder must submit to DMF in Duplicate Authorize FDA to incorporate the DMF information by reference into the “review file” of another company Include date, DMF number, specific sections which may be incorporated if necessary Include commitment you will comply with the statements in the DMF Sign, typed name and title New England Biomedical Research, Inc.
14
FDA Reviews •
•
FDA will review for administrative completeness on receipt, but only perform a substantive review on incorporation by reference into a “Review Document” If deficiencies found, FDA will detail the problems to the DMF holder, and inform applicant with the “review document” that there were deficiencies found
New England Biomedical Research, Inc.
15
Holder Obligations •
• • •
Must notify applicants who have relied on your DMF about impending changes to the DMF in time for applicant to decide regulatory consequences Must list all persons who have a right of reference to the DMF in the Annual Update Must submit Annual Update Foreign holders required to engage US Agent New England Biomedical Research, Inc.
16
Transfer of Ownership •
•
Holder sends letter to FDA transferring ownership, advising of effective date and name of official at new Holder’s facility New Holder sends letter accepting the transfer and committing to honor all commitments of the first holder
New England Biomedical Research, Inc.
17
New England Biomedical Research, Inc.
1
Master Files Are Used To: •
•
Submit confidential information to FDA (information that you don’t want your customer to know, but which he needs for an FDA approval) Submit information known to you that would otherwise have to be included repeatedly in other applications (but this may not be a good practice)
New England Biomedical Research, Inc.
2
Master Files are Used To (cont.): •
•
Insert information into “review” documents by reference. “Review” documents include: NDA’s, NDA Amendments or Supplements ; CTDs and related documents: IND’s or IND Amendments ; ANDA’s, ANDA Amendments or Supplements ; Another DMF (rarely)
New England Biomedical Research, Inc.
3
Master Files are Not: • • •
A substitute for an IND, NDA, CTD, or ANDA Approved or Disapproved as a stand alone document Reviewed by FDA, ever, except in connection with the document in which they are included by reference
New England Biomedical Research, Inc.
4
Types of Drug Master Files • • • • •
Type I - Facilities, personnel, procedures (no longer applicable) Type II - Drug Substance, a substance intermediate or a Drug Product Type III - Packaging Material Type IV - Excipient, Color, Flavor, Essence Type V - Other New England Biomedical Research, Inc.
5
Type I DMF - Facility •
No longer applicable
New England Biomedical Research, Inc.
6
Type II DMF - Drug Substance • •
One per DMF Follow: – “Guideline for Submitting Supporting Documentation in Drug Applications for the Manufacture of Drug Substances” – “Guideline for the Format and Content of the Chemistry, Manufacturing, and Control Section of an Application” – Other guidelines may also apply
New England Biomedical Research, Inc.
7
Type II DMF - Drug Product • •
May need DMF in some cases Follow: – “Guideline for the Format and Content of the Chemistry, Manufacturing, and Control Section of an Application” – “Guideline for Submitting Documentation for the Manufacture and Control of Drug Products” – “Guideline for Submitting Samples and Analytical Data for Methods Validation” – Other guidelines may also apply
New England Biomedical Research, Inc.
8
Type III DMF-Packaging Materials •
•
• •
•
Identify Intended Uses, Components, Composition, Method of Manufacture and Controls for the Packaging Item Identify suppliers of components and controls on receipt of these-obtain a right of reference to their DMF if necessary Enclose Toxicology if required Follow “Guideline for Submitting Documentation for Packaging of Human Drugs and Biologics” Other guidelines may also apply New England Biomedical Research, Inc.
9
Type IV DMF Excipient/Color/Flavor, Etc. •
• •
•
Characterize by method of manufacture, specifications and test methods Include Toxicology if necessary Sources of release tests, Specs. and Safety may be compendial or regulations : Colors-21CFR Part 20-82 ;Food Additives Direct and Indirect-21CFR Parts 170-178; Food Substances-21CFR Parts 181-186 If Novel excipient, follow guidelines for characterization and qualification
New England Biomedical Research, Inc.
10
Type V DMF - Other •
Do not submit without pre clearance from FDA, except – DMFs to describe sterile product manufacturing plants may be filed as Type V DMFs. DMFs. It is not necessary to request prior clearance from FDA before filing such DMFs. DMFs. See Guidance for Industry for the Submission Documentation for Sterilization Process Validation in Applications for Human and Veterinary Drug Products. Products. – Similarly DMFs to describe contract facilities for the manufacture of biotech products may be filed as Type V Master Files without prior clearance from FDA. See Draft Guidance for Industry: Submitting Type V Drug Master Files to the Center for Biologics Evaluation and Research New England Biomedical Research, Inc.
11
General Notes • Type II, III and IV DMF’s require commitment that Environmental Laws will be complied with – If Environmental Assessment needed see 21CFR Part 25 and New Environmental Assessment Guidelines
• If Stability Data Needed, see ICH Guidelines and “Guideline for Submitting Documentation for Stability of Human Drugs and Biologics • Submit in Duplicate • Number Volumes 1 of 3, 2 of 3, etc.
New England Biomedical Research, Inc.
12
General Notes (cont.) • • •
Use 8 1/2 x 11 inch paper Large Drawings must be folded and mounted - no plastic inserts Address to – Food and Drug Administration Center for Drug Evaluation and Research Central Document Room 5901-B Ammendale Road Beltsville MD 20705-1266
New England Biomedical Research, Inc.
13
Authorization Letter • •
•
• •
Holder must submit to DMF in Duplicate Authorize FDA to incorporate the DMF information by reference into the “review file” of another company Include date, DMF number, specific sections which may be incorporated if necessary Include commitment you will comply with the statements in the DMF Sign, typed name and title New England Biomedical Research, Inc.
14
FDA Reviews •
•
FDA will review for administrative completeness on receipt, but only perform a substantive review on incorporation by reference into a “Review Document” If deficiencies found, FDA will detail the problems to the DMF holder, and inform applicant with the “review document” that there were deficiencies found
New England Biomedical Research, Inc.
15
Holder Obligations •
• • •
Must notify applicants who have relied on your DMF about impending changes to the DMF in time for applicant to decide regulatory consequences Must list all persons who have a right of reference to the DMF in the Annual Update Must submit Annual Update Foreign holders required to engage US Agent New England Biomedical Research, Inc.
16
Transfer of Ownership •
•
Holder sends letter to FDA transferring ownership, advising of effective date and name of official at new Holder’s facility New Holder sends letter accepting the transfer and committing to honor all commitments of the first holder
New England Biomedical Research, Inc.
17
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