University:
Northwest College
Course:
VN 210 | Introduction to Pharmacology
Academic year:

2023
Views:

175

Pages:

2
Author:

Lauren P.

Drug Registration Registration is specifically excluded for drugs: a. Special use medications at the request of a doctor; b. Donation Medicine; c. Drugs for Clinical Trials; d. Sample Medicines for Registration. Medicines that have a marketing permit must meet the following criteria: a. Convincing efficacy and adequate safety are proven through animal experiments and clinical trials or other evidence in accordance with the status of scientific development in question. Drugs for clinical trials must be proven to be the drug safe for use in humans. Further provisions regarding the implementation of clinical trials are determined by the Head of the Agency. b. Quality that meets the requirements assessed from the production process in accordance with Good Medicine Manufacturing Practices (CPOB), specifications and testing methods for all materials used and finished products with valid evidence; c. Labeling contains complete and objective information that can guarantee appropriate, rational and safe use of drugs; d. In accordance with the real needs of society. e. Another criterion is that specifically for psychotropics, they must have superior benefits and safety compared to standard drugs and drugs that have been approved for circulation in Indonesia for the claimed indication. Registration Requirements 1. Registration of Domestically Produced Medicines  Registration of domestically produced medicines is only carried out by pharmaceutical industries that have a pharmaceutical industry permit issued by the Minister.  The pharmaceutical industry is required to comply with CPOB requirements.  Fulfillment of CPOB requirements is proven by a certificate CPOB issued by the Head of the Agency. 2. Narcotic Drug Registration  Specifically, registration of narcotic drugs can only be carried out by pharmaceutical industries that have a special permit to produce narcotics from the Minister.  The pharmaceutical industry is required to comply with CPOB requirements.  Fulfillment of CPOB requirements is proven by a certificate CPOB issued by the Head of the Agency. 3. Registration of Contract Medicines  Registration of contract medicines can only be carried out by the contract provider, by attaching the contract documents;      The contract giver is the pharmaceutical industry; The pharmaceutical industry providing the contract is required to have a pharmaceutical industry license and at least having at least 1 (one) production facility for other preparations that meets CPOB requirements The contracting pharmaceutical industry is responsible for quality finished drugs manufactured under contract. The contract recipient is a domestic pharmaceutical industry which is required to have a pharmaceutical industry permit and has implemented CPOB for the contracted preparations. Imported medicines are prioritized for public health program medicines, newly discovered medicines and medicines that are needed but cannot be produced domestically. Registration of imported medicines is carried out by the domestic pharmaceutical industry which has received written approval from the overseas pharmaceutical industry.