PAKISTAN An application for registration of a drug shall be made in Form 1.

An application for registration 5 or 5A in duplicate to the Registration Board addressed to its COMPARISON OF Secretary, and separate application shall be made for each of drug must be submitted to the DRUG REGISTRATION PROCEDURE OF drug. Department of Health, Food and PAKISTAN AND USA Drug Administration in the original prescribed form (Form 1 Registration) 2.Total registration fee is 400 US Rupees one thousand for the registration of new drug; dollars Rupees five hundred for the registration of any other drug. 3.Application for renewal of registration shall be submitted 90 days before the validity of the registration terminates. Failure to adhere to the 90 days requirement may result in disruption of continued validity of registration 4.Same amount is paid for renewal 5.Certificate of registration is renewed every year. Application for renewal of registration of a drug shall be made in Form 5B. An application for the renewal of registration shall not be entertained unless it has been made within sixty days after the expiry of the registration.


Rupees two hundred and fifty for the renewal of the registration of a new or any other drug A certificate of registration under this chapter, shall, unless earlier suspended or cancelled, be. in force for a period of five years from the date of Registration of the drug and may thereafter be renewed for periods not exceeding 5 years at a time 6.The Registration Certificate A certificate of registration of drug shall be issued (Form II) will be issued only in Form 6. when the acknowledgement of receipt of payments is submitted. 7.Premises shall be so inspected by one or more officers or employees duly designated by the Secretary, or by persons accredited to conduct inspections. The Registration Board may, before issuing a registration], cause the premises in which the manufacture is proposed to be conducted to be inspected by itself or by its subcommittee or by a panel of Inspectors or experts appointed by it for the purpose, which may examine all portions of the premises and the plant and appliances, inspect the process of manufacture intended to be employed and the means to be employed for standardising, if necessary, and testing the substances to be manufactured and enquire into the professional qualifications of the technical staff employed Drug sampling is not required unless or until safety, efficacy and quality of new drug isn’t compromised

8. The following kind of drug samples are normally required. Drug samples the quantity of which is sufficient for clinical trial (20g) on sixty patients.. For certain rare diseases fewer numbers of samples may be acceptable. - Samples for laboratory analysis etc. 9. If it is an application for registration of drugs manufactured outside of USA. The Food and Drug

The Registration Board shall, before registering a new drug for which the research work has been conducted in other countries and its efficacy, safety and quality has been established therein, require the investigation on such pharmaceutical,


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