DRUG REGISTRATION

Group 1 INDRI ARYA ASTUTI ANGGI RESTYANA AYUSYA DIAN PRAMITA WIWI HASMITA RINA REZA CHAIRANI

260112110002 260112110004 260112110006 260112110008 260112110010

PROGRAM PROFESI APOTEKER FAKULTAS FARMASI UNIVERSITAS PADJAJARAN 2011/2012

Drug Registration

Registration
Registration is a procedure of drug

registration application and drug evaluation in order to obtain marketing authorization.

Drug criteria
Convincing evidence of efficacy Adequate safety Having quality that fulfils the criteria

concerning the production process in accordance with Good Manufacturing Practice of (GMP/CPOB) Labeling must contains objective and complete information

Category of Drug Registration

Category 1 : new drug registration with new active pharmaceutical ingredient or new derivative or new combination Category 2 : new drug registration with old composition in a new dosage form or new strength Category 3 : old composition with New indication or posology Category 4 : registration of copy drug in trade or generic name Category 5 : other preparation containing drug

Cont :
Category 6 : Category 7 : copy drug which has already obtained a marketing authorization with a modification drug that has obtained a marketing authorization with a modification of label claim which influence drug safety drug which has obtained a marketing authorization with modification drug that has obtained a marketing with a modification or addition to the packaging drug that has obtained a marketing authorization with modification of packaging design, factory name, importer, trade name or packaging size

Category 8 : Category 9 : Category 10:

Procedure of Obtaining Marketing Authorization

Registration

Pre evaluation

Copy drug
evaluation New Drug

Copy drug
Re-evaluation

1
Copy Drug

Comitee of Quality, Technology, labeling, and rationality

Approval

Rejection

Evaluation

New Drug
1
Re -evaluation Approval

New drug

Comitee efication and safety evaluation

Comitee of Quality, Technology, labeling, and rationality Rejection

registration

Herbal Medicine Registration

Registration of Herbal Medicine

To obtain marketing authorization herbal medicine should : 1. Using active ingredients and excipients which fulfill eficacy and safety standart 2. Having quality that fulfill the criteria concerning the production process in accordance with Good Manufacturing Practice of Herbal Medicine 3. Labeling must contains objective and complete information

Procedure of Obtaining Marketing Authorization

1 2 Registration 3
National comitee of herbal medicine evaluation

Reevaluation Approval

4 5 Rejection

Food Suplements Registration

Registration category
New application Category 1 Registration of food supplements containing one or more ingredients Category 2 Registration of food supplements containing one or more ingridients from natural resources Category 3 Are first and second category with new using, dosage form, posology, ang dosis

Variation application Category 4 drug that has obtained a marketing authorization with changing in product name, packaging size, labeling without affecting eficacy, factory name, or importer Category 5 drug that has obtained a marketing authorization with changing in spesification, place of production, packaging size Category 6 drug that has obtained a marketing authorization with changing formula which the active ingridients are from the same group, excipients without changing usage

Procedure of Obtaining Marketing Authorization

Registration 1 Evaluation 2
Comitee of Food Supplements Evaluation Rejection Re-evaluation Approval

3
4

Cosmetics Registration

Criteria
1. The material shoul fullfill the criteria safety

and the final product shouldnt place users in danger 2. Efctifity should match purpose of use 3. Having quality that fulfill the criteria concerning the production process in accordance with Good Manufacturing Practice of Cosmetics 4. Labeling must contains objective and complete information

Procedure of Obtaining Marketing Authorization

Distributor registration

Notification

Registration Payment