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);
- Swissmedic;
- 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.
Contact us:
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.