Pre-marketing Control
Licensing
The Drug Act requires that any person who wishes to sell, manufacture or import drugs into the Kingdom must obtain a licence from the licensing authorities. The Drug Control Division is the licensing and registration authority for manufacturing, import and sale of drugs within Bangkok metropolis and its territories. Provincial Public Health Offices are the licensing authorities for manufacture and import of traditional drugs and sale of drugs in other p rovinces.
Applications for licences must be submitted to the licensing authority. Their buildings and facilities will then be inspected. A licence will be issued after the inspection has confirmed that the applicant has adequate capabilities of doing such business, and he/she can secure appropriate facilities and personnel for that purpose.
Licences are issued, according to the business of the applicant, in nine different categories:
- Licence to manufacture modern medicines
- Licence to import modern medicines
- Licence to sell modern medicines
- Licence as a wholesaler of modern medicines
- Licence to sell modern medicines in sealed packages which are classified as neither dangerous nor specially-controlled medicines
- Licence to sell modern veterinary medicines in sealed packages
- Licence to manufacture traditional medicines
- Licence to sell traditional medicines
- Licence to import traditional medicines
Drug Registration
The registration process is necessary to ensure quality, safety and efficacy of the drugs being marketed in the country. Only authorized licensees are qualified to apply for product registration. Manufacturing plants, in which drug products are manufactured, are subject to inspection for GMP compliance.
According to the new Drug Act (expected to be enacted within 2003), a certificate of product registration is valid for five years as from the date of issuance. The process of drug registration will be carried out in 2 channels, which differ in degrees of control and dossier submission:
- Registration of general medicines
- Registration of Thai traditional medicines
Due to some differences in the requirements for dossiers to be submitted for product approvals, the general medicines will have to be further defined as:
- Generics whose registrations require only dossiers on product manufacturing and quality control along with product information;
- New medicines whose registrations require a complete set of product dossiers;
- New generics whose registrations require dossiers of bioequi-valence studies in addition to the required dossiers for generics submission.
Generics mean pharmaceutical products with the same active ingredients and the same dosage forms as those of the original products, but manufactured by different manufacturers.
New medicines include products of new chemicals, new indications, new combinations or new delivery systems and new dosage forms.
New generics are medicines with the same active ingredients, doses and dosage forms as those of the new compounds registered after 1992.
The amended registration procedure for new drug products, adopted in August 1989, involves a two-year period of safety monitoring program. This means that new drug products will be firstly approved for use only in hospitals or clinics for at least two years. Then safety reports must be submitted for consideration as to whether general marketing should be allowed. Meanwhile, new generic products have to pass bioequivalence studies to assure comparatively therapeutic outcomes. The bioequivalence data must be submitted to the authorities as proofs of the product bioavailability along with product information and quality dossiers.
Quality assurance of drug safety and efficacy before marketing can undoubtedly be achieved through good manufacturing practices. Inspection of drug manufacturers and sampling of drug samples from manufacturers, importers or retail pharmacies for analyses by the regulatory authorities cannot effectively solve the problems encountered. Drug manufacturers, importers and distributors must establish their quality assurance systems according to the GMP guidelines to ensure that the drug products have and continue to have the quality as claimed.
The Thai FDA has begun campaigning on GMP compliance since 1984. Projects on development of local pharmaceutical industry up to internationally acceptable standards were part of the Sixth National Economic and Social Development Plan (1987–1991) and also of the Seventh Plan (1992–1996). The projects aimed to promote and support local drug manufacturers in implementing good manufacturing practices. The first guidelines of Thai Good Manufacturing Practices were published in 1987. Since then numerous workshops, seminars and conferences as well as consultative visits have been held or carried out to promote the guidelines adoption.
Control of Drug Advertisement
Drug information available to health-care professionals and consumers is as important as drug quality for the safe use of drugs. Drug advertisements and other promotional materials need to ensure truthfulness and non-exaggeration. Advertisements through any means must be approved by the authorities before actually being disseminated. Advertisements of prescription or pharmacy-dispensed medicines are permitted only to professionals but prohibited to the general public. Drugs in the household remedy category may be advertised directly to consumers or the general public.
The control of drug advertisements is presently focused on the increasing advertisements on the Internet. A majority (>85%) of such advertisements are being run without FDA permission. Due to the fast growing numbers of and difficulties in catching up with these advertisements, the monitoring of violation as well as guidelines and measures for the violation control must therefore be comprehensive and updated periodically.
