Version of 14 Feb 2015
Annex 4
Collaborative Procedure in Assessment and Accelerated National Registration of Pharmaceutical Products Approved by Stringent Regulatory Authorities – Pilot Assisted the by the WHO Prequalification Team.
Proposed documentation for collaborative registration process for SRA-approved medicinal products
Notes:
For the pilot phase, it is proposed to select such SRA approved dossiers, for which the API section is covered by an APIMF or a CEP.
The format of the documentation corresponds to CTD in accordance with ICH format/content . From practical reasons non/clinical (Modul IV) and clinical data (Modul V) are replaced by summaries included in Module II. Should there be a need of more extensive data from the Modul IV and Modul V, these are available on request.
Confidentiality of submitted data and no-disclosure to a third party is – in addition to relevant national legislation and organizational measures applied by NMRs participating in the pilot - assured by a commitment on confidentiality that represents integral part of the piloted Procedure[1] (Annex 1), is signed by representatives of participating NMRAs and archived by WHO-PQT.
ADAPTED MODULE 1
/ Documentation to be provided / Comments /1.0 / Letter of application / Cover letter in English or French as applicable to the region
Attachments to the Letter:
Annex 3A of the SRA procedure
Annex 3B of the SRA procedure
Annex 5 / Includes information as specified in Commitment letter 1 (additional administrative data) and Commitment letter 2 (additional stability data for climatic zones). Any differences in dossier submitted to SRA should be explained, including differences in Product Information. / Submitted in English or French as applicable to the region
1.1 / Comprehensive Table of Contents / Comprehensive TOC including Module 1 information
1.2 / Quality Information Summary (QIS) / This will be included instead of a country-specific application form / Same as the one used in the WHO PQ submissions.
To be included in the adapted Module 1
1.3 / Product Information
1.3.1 / Package Insert or SmPC / Product information as applicable for region where application will be submitted / Submitted in English or French as applicable to the region
1.3.2 / Patient Information Leaflet or Package leaflet / Mock-ups / Submitted in English or French as applicable to the region
1.3.3 / Labeling / Mock-ups / Language and information to reflect national requirements
1.4 / Marketing Authorisation from SRA
1.4.1 / Marketing Authorisation from SRA / YES
1.4.2 / Assessment report from SRA
(Access to the full assessment report from the SRA used as reference country, if available) / Agreement from the company to allow SRA to share the report with WHO and NRAs. Prior to sharing, the SRA and company should agree on the content of the document that is shared. If fully justified, sentences referring to highly confidential information and/or highly sensitive data and/or not related to the product assessment data could be masked / Please note that this time of document is available only if product registered in Europe, via Centralized Procedure
Public reports are preferred as they already contain all useful information except those considered to give a competitive advantage.
The sharing process is facilitated by WHO, between SRA and NRAs.
1.5 / GMP Certification
1.5.1 / Copy of the GMP certificate of the API supplier, if available / YES
If not available, statement signed by drug product site QP to be provided / Not always available for the time being.
No legalization is required…
1.5.2 / Copy of the GMP certificate of the FPP manufacturer(s) / YES / No legalization is required
1.5.3 / GMP inspection report of the manufacturing site(s) (FPP) from any SRA / Agreement from the company to allow SRA to share the report with WHO and NRAs. Prior to sharing, the SRA and company should agree on the content of the document that is shared. If fully justified, sentences referring to highly confidential information and/or highly sensitive data and/or not related to the product assessment data could be masked / Public reports are preferred as they already contain all useful information except those considered to give a competitive advantage.
The sharing process is facilitated by WHO, between SRA and NRAs.
1.6 / Other Documentation
If generic dossier:
Full GCP inspection report of the bioequivalence study from any SRA, if any / Agreement from the company to allow SRA to share the report with WHO and NRAs. Prior to sharing, the SRA and company should agree on the content of the document that is shared. If fully justified, sentences referring to highly confidential information and/or highly sensitive data and/or not related to the product assessment data could be masked / Public reports are preferred as they already contain all usefull information except those considered to give a competitive advantage.
The sharing process is facilitated by WHO, between SRA and NRAs.
ADAPTED MODULE 2
/ Documentation to be provided/comments / comments /2.3 / Quality Overall Summary / YES / In accordance with ICH CTD format (and not WHO PQP template) /
2.6 / Non clinical summary * / YES / No submission of 2.4
Module 2.6 identical to the one submitted to the SRA
*See documentation requirement for line extensions below /
2.7 / Clinical Summary ** / YES / No submission of 2.5
Module 2.7 identical to the one submitted to the SRA /
* In case of line extension, since 2.6 is usually not available (since we cross refer to the initial NDE) we do provide 2.4 and 2.5 and 2.7 (if available).
**In the case of generic medicines where a Clinical Summary is not available, the Clinical Overview (Module 2.5) should be included.
MODULE 3 CMC DOCUMENTATION
3.2. / BODY OF DATA (CTD FORMAT) / To be provided/comments / comments /For each active substance
3.2.S / DRUG SUBSTANCE / Corresponding to the open part of the APIMF
3.2.S.1 / General Information / YES
3.2.S.1.1 / Nomenclature / YES
3.2.S.1.2 / Structure / YES
3.2.S.1.3 / General Properties / YES
3.2.S.2 / Manufacture / YES
3.2.S.2.1 / Manufacturer(s) / YES
3.2.S.2.2 / Description of manufacturing process and process controls / YES
3.2.S.2.3 / Control of materials / YES
3.2.S.2.4 / Controls of critical steps and intermediates / YES
3.2.S.2.5 / Process validation and/or evaluation / YES
3.2.S.2.6 / Manufacturing process development / YES
3.2.S.3 / Characterization / YES
3.2.S.3.1 / Elucidation of structure and other characteristics / YES
3.2.S.3.2 / Impurities / YES
3.2.S.4 / Control of drug substance / YES
3.2.S.4.1 / Specification / YES
3.2.S.4.2 / Analytical procedures / YES
3.2.S.4.3 / Validation of analytical procedures / YES
3.2.S.4.4 / Batch analyses / YES
3.2.S.4.5 / Justification of Specification / YES
3.2.S.5 / Reference standards or materials / YES
3.2.S.6 / Container closure system / YES
3.2.S.7 / Stability / YES
3.2.S.7.1 / Stability summary and conclusions / YES
3.2.S.7.2 / Post-approval stability protocol and stability commitment / YES
3.2.S.7.3 / Stability data / YES
3.2.P / DRUG PRODUCT
3.2.P.1 / Description and composition of the drug product / YES
3.2.P.2 / Pharmaceutical development / YES
3.2.P.2.1 / Components of the Drug Product (name, dosage form) / YES
3.2.P.2.1.1 / Drug Substance (name, dosage form) / YES
3.2.P.2.1.2 / Excipients (name, dosage form) / YES
3.2.P.2.2 / Drug Product (name, dosage form) / YES
3.2.P.2.2.1 / Formulation Development (name, dosage form) / YES
3.2.P.2.2.2 / Overages (name, dosage form) / YES
3.2.P.2.2.3 / Physicochemical and Biological Properties (name, dosage form) / YES
3.2.P.2.3 / Manufacturing Process Development (name, dosage form) / YES
3.2.P.2.4 / Container Closure System (name, dosage form) / YES
3.2.P.2.5 / Microbiological Attributes (name, dosage form) / YES
3.2.P.2.6 / Compatibility (name, dosage form) / YES
3.2.P.3 / Manufacture / YES
3.2.P.3.1 / Manufacturer(s) / YES
3.2.P.3.2 / Batch formula / YES
3.2.P.3.3 / Description of manufacturing process and process controls / YES
3.2.P.3.4 / Controls of critical steps and intermediates / YES
3.2.P.3.5 / Process validation and / or evaluation / YES
3.2.P.4 / Control of excipients / YES
3.2.P.4.1 / Specifications / YES
3.2.P.4.2 / Analytical procedures / YES
3.2.P.4.3 / Validation of analytical procedures / YES
3.2.P.4.4 / Justification of specifications / YES
3.2.P.4.5 / Excipients of human or animal origin / YES
3.2.P.4.6 / Novel Excipients (ref to A 3) / YES
3.2.P.5 / Control of drug product / YES
3.2.P.5.1 / Specification(s) / YES
3.2.P.5.2 / Analytical procedures / YES
3.2.P.5.3 / Validation of analytical procedures / YES
3.2.P.5.4 / Batch analyses / YES
3.2.P.5.5 / Characterization of impurities / YES
3.2.P.5.6 / Justification of specification(s) / YES
3.2.P.6 / Reference standards or materials / YES
3.2.P.7 / Container closure system / YES
3.2.P.8 / Stability / if zone III – IV are not available, commitment and protocol will be joined; and if any, any preliminary data will be provided for these conditions (see commitment letter)
3.2.P.8.1 / Stability summary and conclusions / YES
3.2.P.8.2 / Post approval stability protocol and stability commitment / YES
3.2.P.8.3 / Stability data / YES
3.2.A / APPENDICES
3.2.A.1 / Facilities and equipment / -
3.2.A.2 / Adventitious agents safety evaluation / YES
3.2.A.3 / Excipients / -
3.2.R / REGIONAL INFORMATION
Copy of the certificate of analysis of the finished product / YES
3.3 / LITERATURE REFERENCES / If any
1
[1] Collaborative Procedure in Assessment and Accelerated National Registration of Pharmaceutical Products Approved by Stringent Regulatory Authorities. The pilot assisted the by the WHO Prequalification Team.