Master Files with ectd

Transcription

1 Master Files with ectd Follow-up Information Meeting Step 2 Dr. Christoph Berger August 31, 2010 Swissmedic Schweizerisches Heilmittelinstitut Hallerstrasse 7 CH-3000 Bern

2 Overview 1. Master Files in general 2. Drug Master Files 3. Plasma Master Files 4. Conclusions 2

3 Master Files Swissmedic There are three types of Master Files: Drug Master Files (DMF) Plasma Master Files (PMF) Vaccine Antigen Master Files (VAMF) so far not submitted at Swissmedic 3

4 Submission of Master Files Submitted by DMF/PMF holder Along with an application by MAH New application NAS (ZL101) Variations requiring notification (ZL301) Variations requiring authorisation (ZL302) Once ectd, always ectd DMF/PMF submission should not precede submission of drug product documentation CDs/DVDs for paper submission are welcome 4

5 Overall principle of submitting sequences Example of life cycle management of Master File Sequence Initial application Responses to questions 0002 Responses to pre-decision Variation 1 Responses to questions 0005 Variation 2 5

6 Status Master Files / Documentation of Applicant Hybrids paper / ectd are possible: DMF/PMF ectd Paper DMF/PMF ectd Paper DMF/PMF Drug product documentation ectd ectd Paper P-Doc Paper P-Doc 6

7 Overview 1. Master Files in general 2. Drug Master Files 3. Plasma Master Files 4. Conclusions 7

8 Drug Master Files DMF Principle: The Master File is a stand alone dossier (own life cycle) Electronic submissions for DMFs should be in the ectd format Consists of restricted part (RP), applicant part (AP), Cover Letter, Letter of Access, Swissmedic forms Submission of baseline for DMF/PMF without concurrent variation is possible A consolidation sequence has to be submitted if necessary Generally: Envelope and M1 according to Swiss Module 1 Specification 8

9 DMF Envelope Element invented name Perfesub (Farma SA) Element application type = dmf Element submission description indicate version no Element related ectd Sequence refers to DMF/PMF life cycle For elements related exclusively to final product n/a (e.g. galenic form) Element applicant n/a (information is given using Form DMF) For a variation of a DMF/PMF the element application type should indicate supplemental-info 9

10 Example DMF Envelope 10

11 DMF - Module 1 The country code should be used Module 1 CH Cover letter has always life cycle operator new Form DMF for first Authorisation and Variations (M ) is to be included in the life cycle of the DMF and the life cycle of the drug product. Part A is filled in by the applicant (MAH), a copy of it is transferred to the DMF holder, the form gets completed by filling in Part B by the DMF Holder. Letter of Access (M ) is to be included in the life cycle of the DMF and the life cycle of the drug product. Signed paper copies of Letter of Access and Form DMF for first Authorisation and Variation must be provided. 11

12 DMF - Module 1/2/3 The prefix RP or AP should be added to <substance> metadata value, every leaf title in the respective section (RP=Restricted Part, AP=Applicant Part). It is also recommended to add RP or AP to the file names. Documents that are the same in both the AP and RP sections should be included only once and placed in the AP section of the folder structure. The leaf in the RP section will therefore point to the file in the AP section folder. 12

13 Example DMF Module (I) 13

14 Example DMF Module (II) 14

15 Overview 1. Master Files in general 2. Drug Master Files 3. Plasma Master Files 4. Conclusions 15

16 Plasma Master Files PMF (I) Principle: The Master File is a stand alone dossier (own life cycle) Electronic submissions for PMFs should be in the ectd format Annual updates Expert statement to be put under Module 2.3 of the drug product 16

17 Plasma Master Files PMF (II) Documentation to be provided Generally: Envelope and M1 according to Swiss Module 1 Specification Signed declaration that the PMF dossier and the certificate can be applied to the drug product M1 Additional information Copy of the EMA PMF certificate (without annexes) M Copy of the EMA evaluation report M1.7.2 Complete documentation for Module 2.3 and 3 is needed, also when there is a EMA evaluation report 17

18 Overview 1. Master Files in general 2. Drug Master Files 3. Plasma Master Files 4. Conclusions 18

19 Conclusions Swissmedic is ready to accept new DMF/PMF and variations to DMF/PMF (step 2 of SIMES) Timelines remain unchanged There is still limited experience with ectd of DMF/PMF In case of questions, please contact Swissmedic (esubmission@swissmedic.ch) 19

20 Thank you for your attention! 20