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                                                    Laws and Regulations
 
The Drug Act of B.E. 2510 (1967) is currently stilled in effect, whereas the new Drug Act of B.E.2546 (2003) is in the final stage of promulgation. Attempts to revise the Drug Act of B.E. 2530 (1987) are painstaking and time-consuming. When it becomes effective, many features will be changed accordingly, for example:

1.Types of medicines will be reclassified into 3 new categories: prescription-only, pharmacy-dispensing and household remedies.

2.Physicians will no longer be allowed to compound medicines for their patients.

3.Manufacturers who are unable to comply with the good manufacturing practices (GMP) principles can no longer proceed with the drug business.

4.The new law provides more flexibility for revising the GMP requirements. Under the new law, the GMP requirements may be revised and approved by the Drug Committee and declared by the Minister of Public Health; no need to get approval from the Parliament as required in the 1987 law.

5.Government-owned enterprises or agencies will no longer be exempted from the requirements of licensing and product registration.

6.Pharmaceutical products may be registered in either of the two channels: one for general medicines and the other for Thai traditional medicines.

7.Product licences must be renewed every five years.

8.The Drug Committee will be authorized to withdraw any drug products if later evidence proves that the products are not scientifically efficacious.

9.The Food and Drug Administration will be able to declare certain charges for its services related to licensing, registration, dossier evaluation and approval processes, including expenses for testing the products.

10.Product liability will be implemented for the first time. Consumers may directly sue and get compensation from drug manufacturers if there is any serious harm occurring to them after consumption, provided that product indications are strictly followed.

11.The deviation of statements in advertisement from those permitted will have to be made known to the public through further apology advertisement along with the correct statements.

12.The amounts of fines will be increased up to tenfold, compared to the previous ones.

13.A pharmacist will be allowed to work in as many drugstores as he/she can.

Regulatory Procedures

According to the Drug Act, the Drug Committee is appointed by the Minister of Public Health every two years to advise him/her on both regulatory and technical aspects concerning the administration of pharmaceutical control. The committee is also authorized to approve or withdraw pharmaceutical registration, standard specifications, criteria and guidelines, including suspending or withdrawal of licences to manufacture, import, distribute or sell. There are 14 regular members on the Drug Committee: five of them being ex officio members who are appointed based on their positions in pharmaceutical-related organizations and the others being appointed from among pharmaceutical and medical experts. The Committee can then appoint subcommittees to assist them with certain tasks. Presently, nineteen subcommittees have been appointed:

1.Subcommittee on review and approval for registration of traditional and herbal medicines

2.Subcommittee on review and approval for registration of modern medicines (new drugs) for human use

3.Subcommittee on review and approval for registration of modern medicines (generic drugs) for human use

4.Subcommittee on review and approval for registration of modern medicines (biological products) for human use

5.Subcommittee on review and approval for registration of modern medicines for veterinary use

6.Subcommittee on re-evaluation of registered medicines for human use

7.Subcommittee on surveillance of safety of drug utilization

8.Subcommittee on review and approval of drug advertisements

9.Subcommittee on establishment of good manufacturing practices (GMP) requirements

10.Subcommittee on approval of manufacturing or importing medicines for clinical studies

11.Subcommittee on establishment of requirements for bioequivalence studies

12.Subcommittee on GCP inspection of clinical studies

13.Subcommittee on establishment of guidelines on problem-solving of pharmaceutical raw materials and products for veterinary use

14.Subcommittee on evaluation and approval of pharmaceutical quality and testing for compliance with quality standards

15.Subcommittee on licensing approval of manufacturers, importers, distributors and drugstores

16.Subcommittees on specific assignments:

a.Subcommittee on policy development and promotion of biological products

b.Subcommittee on establishment of requirements for biological products

c.Subcommittee on the exemption of certificates of free sale in the registration of certain products (such as Remune)

d.Subcommittee on approval for registration of growth hormone products.




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Drug act B.E.2510 and its amendments PDF

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