A Plasma Master File (PMF) must be submitted for all plasma-derived therapeutic products containing an active or inactive ingredient that is derived from human blood.
Documents pertaining to the collection and control of source materials should be provided as a standalone PMF.
Reference to the relevant PMFs may be made in either one of the following sections of the dossier:
- CTD section 3.2.S.2.3, if the PMF relates to the drug substance.
- CTD section 3.2.R.1 (ICH CTD) or 3.2.Q.1 (ACTD), if the PMF relates to an excipient.
Once a PMF or a dossier section on plasma collection and control information is received as a separate standalone document, a PMF number will be assigned to the document. You may cross-reference an existing PMF for a product application if an updated PMF has been submitted to us for another product application in which you are also the registrant.
Submit one set of the PMF in a CD/DVD with the application dossier. The original hardcopies are not required.
The PMF should contain the following information:
- Plasma source and collection.
- Epidemiological data on blood transmissible infections.
- Characteristics of donations and selection/exclusion criteria.
- Testing of blood/plasma donations and pools for infectious agents.
- Plasma quality and safety.
- Conditions of storage and transport of plasma.
- A copy of the plasma specification and plasma pool batch analysis data.
Ensure that the PMF data conforms to the recommended requirements based on the following documents:
- Guideline on Plasma-derived Medicinal Products (EMA/CHMP/BWP/706271/2010).
- Guideline on the Scientific Data Requirements for a Plasma Master File (PMF) Revision 1 (CPMP/BWP/3794/03 Rev. 1).
- Annexes to Guideline on the Scientific Data Requirements for Plasma Master File.
Refer to our Guideline on the Registration of Human Plasma-derived Therapeutic Products79 KB for more information on the data requirements of a PMF.
How to submit a PMF
You may submit the PMF to:
Therapeutic Products Branch
Health Sciences Authority
11 Biopolis Way
Level 11, Helios
PMF life-cycle management
As an applicant, you are responsible for keeping the PMF updated. You will also need to send PMF updates annually to the Therapeutic Products Branch with reference to the assigned PMF number. Annual PMF updates should not be submitted via PRISM.
If a new PMF is submitted for a currently-registered drug product, it should be submitted as a MIV-1 application in PRISM, according to B17: Addition or Replacement of New Plasma Master File (PMF) to registered human plasma-derived product of Appendix 14689 KB.
Note: If a currently-registered PMF contains an update or amendment, the product registrant is responsible for updating us for either one of the following scenarios:
- If the update or amendment is a significant change (e.g. significant changes to the plasma processing), submit it as soon as it is made known.
- If the update or amendment is not a significant change (e.g. a change of collection centres), submit it as part of the annual update.