The International Pharmaceutical Regulators Programme (IPRP) Quality Working Group (QWG) has established a pilot project to create a database that captures administrative information associated with selected ASMFs/DMFs that are filed with participating Regulatory Authorities/Organisations. The IPRP QWG members participating in this pilot project are listed below:
- Agencia Nacional de Vigilancia Sanitaria (ANVISA);
- European Directorate for the Quality of Medicines and Healthcare (EDQM);
- European Commission (EC) / European Medicines Agency (EMA);
- Federal Commission for the Protection against Sanitary Risk (COFEPRIS);
- Health Canada;
- Health Sciences Authority (HSA);
- Instituto Nacional de Vigilancia de Medicamentos y Alimentos (INVIMA) ;
- Ministry of Food and Drug Safety (MFDS);
- Ministry of Health, Labour and Welfare (MHLW) / Pharmaceuticals and Medical Devices Agency (PMDA);
- South African Health Products Regulatory Authority (SAHPRA);
- Taiwan Food and Drug Administration (TFDA);
- Therapeutic Goods Administration (TGA); and
- World Health Organization (WHO).
The IPRP ASMF/DMF Database has been set up in order for the participating Regulatory Authorities / Organisations to identify common ASMFs/DMFs submitted to them for selected Active Pharmaceutical Ingredients (APIs). For the pilot phase, only a limited number of APIs are included in the scope of the project (a list of about 20 APIs of common interest has been established by the group).
The IPRP ASMF/DMF Database will include administrative information of selected ASMFs/DMFs submitted into the participating Regulatory Authorities, and will contain only the following specific details:
- Regulatory Authority/Organisation and date of submission of the ASMF/DMF to the agency;
- Active Pharmaceutical Ingredient (API) name;
- Chemical Abstracts Service (CAS) number;
- Applicant’s Part and Restricted Part version numbers and dates;
- ASMF/DMF Holder details (e.g., name, address, contact information);
- Names and address of the manufacturer for the final API;
- Whether the API is manufactured as sterile or non-sterile.
This database is stored in a non-public secure environment, hosted by the EDQM, which is accessible only by the above mentioned participating Regulatory Authorities/Organisations. The database contains neither the ASMF/DMF dossiers themselves, nor any assessment reports prepared by the participating Regulatory Authorities/Organisations. The participating Regulatory Authorities / Organisations confirm that the information contained in the database will be treated fully confidentially and that they will gather prior consent from the ASMF/DMF holder for each report they wish to exchange.
The database provides a unique opportunity for information sharing with regards to ASMF/DMFs, and the participating Regulatory Authorities/Organisations. The ultimate goal of these endeavours is greater regulatory cooperation, leading to faster and more consistent ASMF/DMF assessments among Regulatory Authorities/Organisations. However, the scope of this pilot project is limited only to the sharing of administrative information that describes an ASMF/DMF.
Tthe pilot phase started on 1st October 2018, and a review of the activities around the database will be carried out.
The IPRP QWG welcomes comments on any practical matters that may need to be considered to make this pilot project a success. Any question about this project may be sent to the IPRP secretariat - IPRPsecretariat@ich.org.
Additionally, any specific queries may be addressed directly to the regulatory authorities/organisations participating in this pilot.