“Drugs” to be manufactured, imported or ordered into the country are regulated as follows:
2.1 “Finished pharmaceutical product”, meaning finished product for human or animal use, requires a drug registration with the Food and Drug Administration prior to the manufacturing, importation or ordering into the Kingdom. Once the drug has been registered, certain types of pharmaceutical products may require further special procedure, for instance:
2.1.1 “Pharmaceutical products that require manufacturing lot approval prior to its distribution”, i.e., human vaccines and plasma-derived pharmaceutical products for human use, once registered under 2.1, must receive a Certificate of Lot Release from the Department of Medical Sciences prior to their distribution or handing over to the users. For veterinary vaccines, a Certificate of Lot Release from the Food and Drug Administration is required prior to its distribution or handing over to the users.
2.1.2 “Drugs according to a Notification of the Ministry of Commerce”, which are finished pharmaceutical products or raw materials for drug manufacturing listed under a Notification of the Ministry of Commerce, once registered under 2.1 or notified under 2.2, must receive a certificate of approval from the Food and Drug Administration before applying for the importation permission from the Ministry of Commerce.
2.2 “Active pharmaceutical ingredients”, being raw materials which are an active ingredient, must be notified to the Food and Drug Administration prior to the manufacturing, importation or ordering into the Kingdom.
A person granted a drug approval must comply with the rules and best practices regarding drug facilities prescribed by laws, as well as the conditions prescribed under the drug registration, such as Good Manufacturing Practice (GMP) compliance, pharmaceutical quality management, and conditions for drug distribution. However, in the case of the manufacturing, importation or ordering of drugs into the Kingdom under section 13 and section 79 bis of the Drugs Act, B.E. 2510 (1967) and its amendments, since those provisions prescribe specific steps, procedures, rules, and conditions, for instance, for importation of drugs for clinical studies, importation of drugs for exhibition, and importation of drugs for donation, etc., these specific provisions of law shall apply instead.
Details of Pharmaceutical Product Registration and Approval
2.1 Pharmaceutical products for general sale Finished pharmaceutical products
After obtaining a license for a drug facility, the licensed manufacturer or importer must register the product intended to be manufactured or imported with the Food and Drug Administration. The documents must be prepared in accordance with the ASEAN COMMON TECHNICAL DOSSIER (ACTD) or the ICH Common Technical Document (ICH CTD). The forms of drug registration with the Food and Drug Administration vary depending on the risks associated with each type of product, for instance, the registration of new drugs or new biological products. Consultation with the Medicines Regulation Division is available to facilitate the thorough preparation of documents. Please note that fees will be charged when applying for the approval.
Active pharmaceutical ingredients for the manufacturing of drugs
Raw materials which are active ingredients for the manufacturing of drugs, also called “active pharmaceutical ingredients”, must be notified as pharmaceutical chemicals, and the manufacturing facilities of such raw materials must meet the manufacturing standards approved by the Food and Drug Administration, such as the GMP standards. Notification fees for pharmaceutical chemicals will be charged.
Application for certification/approval document prior to importation
In addition to drug registration, certain drugs may require a certification or approval document prior to the importation, as follows:
- For human vaccines, plasma-derived products, and biological products prescribed in the list under a Notification, a Certificate of Lot Release must be obtained from the Institute of Biological Products, Department of Medical Sciences before the products can be distributed or handed over to the users. For veterinary vaccines, a Certificate of Lot Release must be obtained from the Food and Drug Administration before the products can be distributed or handed over to the users.
- For drugs which could potentially be misused or which require strict import restrictions according to the list of drugs prescribed in a Notification of the Ministry of Commerce, such as drugs belonging to the beta-agonist group, an approval document must be obtained prior to the importation.
2.2 Pharmaceutical products for specific purposes
In addition to general sale, drugs may be manufactured or imported for the following purposes:
1) as a drug sample for the purpose of registration application;
2) for clinical trials involving human subjects;
3) for analysis;
4) for donation to healthcare facilities;
5) for exhibitions.
To view specific steps, rules, procedures, and conditions specified for each of these purposes, please refer to the Notifications pertaining to that purpose.