From October 15, 2019, What is the Purpose of the Promulgated Rare Drug List?

Specifically:, the List of Rare Drugs issued in the Appendix attached to Circular 26/2019/TT-BYT includes:

1. List of drugs for the prevention, diagnosis, and treatment of rare diseases.

2. List of drugs that are not readily available.

The issuance of the List of Rare Drugs holds significant importance in the diagnosis and treatment of rare diseases. Specifically:, Article 3 of Circular 26/2019/TT-BYT stipulates that the issuance of the List aims to achieve the following purposes:

Illustrative image (source: internet)

Firstly: The List of drugs for the prevention, diagnosis, and treatment of rare diseases is the basis for:

- Competent state agencies to consider exemption or reduction of clinical data, exemption of one or several stages of clinical drug trials before granting marketing authorization for drugs as stipulated in Clause 3, Article 18 of Circular 32/2018/TT-BYT dated November 12, 2018, issued by the Minister of Health, regarding drug registration and drug materials;- Competent state agencies to consider stability study data on the drugs as stipulated in point a, Clause 2, Article 25 of Circular 32/2018/TT-BYT;- State regulatory agencies to prioritize the procedures and processes in drug registration as stipulated in Clause 1, Article 34 of Circular 32/2018/TT-BYT;- State regulatory agencies to grant import licenses for drugs according to legal provisions;- Implementation of reimbursement for drug wastage costs as per regulations on the wastage rate of drugs and the reimbursement of drug wastage costs at medical examination and treatment facilities.

Secondly: The List of drugs that are not readily available is the basis for:

- State regulatory agencies to prioritize the procedures and processes in drug registration as stipulated in Clause 1, Article 34 of Circular No. 32/2018/TT-BYT;- State regulatory agencies to grant import licenses for drugs according to legal provisions;- Implementation of reimbursement for drug wastage costs as per regulations on the wastage rate of drugs and the reimbursement of drug wastage costs at medical examination and treatment facilities.

See additional related provisions at Circular 26/2019/TT-BYT, effective from October 15, 2019.

Thu Ba

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