Registration Fee A. Generic Drug : USD2,700 New Generic Drug : USD3,500 New Drug : USD6,000 B. Biological Product : New Biological Products : USD10,000 Conventional Biological P...
Food and Drug Administration
Medicines are classifies into two major groups: general and traditional medicines.
General medicines are further divided into four categories as per The Drug Act of B.E. 2510 (1967) ,namely 1) household remedies whose sales require no licence: 2) ready-packed drugs that can be sold in drugstores by nurses or other medical professionals: 3) dangerour drugs; and 4) specially controlled drugs. Dangerous drugs which may possess a potentially harmful effect on health, if misused, will be listed in the last category whose sales require a prescription.
The Drug Act of B.E.2546 ( 2003) Types of medicines will be reclassified into 3 new categories: prescription-only, pharmacy-dispensing and household remedies
1. Modern Drug categories 2-3 and 4 are consist of Chemical Drug and Biological Drug
1.1 Chemical Drug included New Drug , New Generic Drug and Generic Drug
- New drug is New Chemical Entities, New Indication , New Combination, New Delivery System, New Route of Administration, New Dosage Form , New strength .
The registration require a complete set of product dossiers (Clinical Document require to submit)
- New Generic Drug are medicines with the same active ingredients, doses and dosage forms as those of the new compounds registered after 1992. The registration require dossiers of bioequi -valence studies in addition to the required dossiers for generics submission.
- Generic Drug mean pharmaceutical products with the same active ingredients and the same dosage forms as those of the original products, but manufatured by different manufacturers but must not have new indication. The registration require dossiers on product manufacturing and quality control along with product information.
1.2 Biological Drug is allergens , antigens, vaccines , hormones , cytokines , enzymes , product from stem cells, product from tissues, product from human whole blood and plasma derivatives, immune sera, immunoglobulins, monoclonal antibodies, product from fermentation or DNA recombinant or drug produce with the following method:
A. Eukaryotic Cells
B. Extraction of substances from biological tissues including human, animal and plant tissue (allergen).
C. Recombinant DNA or rDNA techniques.
D. Hybridoma Technique.
E. Propagation of microorganisms in embryo or animals.
F. Others methods that mentioned by Ministry of Public Health.
Remark: Above mentioned excluded antibiotic and general drug that able to analyse the purity , potency and composition by chemical and physiochemical method except Vaccine.
1.2.1 There are two types of biological drug 1. New Biological Products and 2. Conventional Biological Products
126.96.36.199 New Biological Products included :
- New Biological Active Pharmaceutical Ingredients: New Derivatives, New Complex Substances, New Ester, New Salt, New Strain And never been registered in Thailand before the date submission registration application.
- New Indication
- New Combination
- New Route of Administration
- New Dosage Form
- New Strength
- Genetic engineering of Other newer biotechnological techniques
- New Source of Origin
The registration require a complete set of product dossiers e g. product information , manufacturing process ,quality control ,non-clinical documents along with clinical documents 4 sets.
188.8.131.52 Convertional Biological Products is products with the same active ingredients and the same dosage forms as those of the original biological products, but manufatured by different manufacturers . The registration require a complete set of product dossiers e g. product information , manufacturing process ,quality control ,non-clinical documents along with clinical documents 2 sets.
1.2 Traditional Drugs are those intended to be used in indigenous or traditional medical care as monographed in the official pharmacopoeia of traditional medicines or those declared by the Minister of Public Health as traditional medicines or those permitted to be registered as traditional medicines. The control and registration of drugs in this group are less stringent than those for modern drugs.
(Source : Thailand FDA)
III. Medical Devices
VII. Veterinary products