7/31/2019 Comparison of Drug Registration Procedure of Pakistan
With Usa
1/2
COMPARISON OF DRUG REGISTRATION PROCEDURE OF
PAKISTAN AND USA
USA PAKISTAN
1.An application for registration
of drug must be submitted to theDepartment of Health, Food
and
Drug Administration in the
original prescribed form (Form 1
Registration)
An application for registration of a drug shall be made in
Form
5 or 5A in duplicate to the Registration Board addressed to
its
Secretary, and separate application shall be made for each
drug.
2.Total registration fee is 400 US
dollars
Rupees one thousand for the registration of new drug;
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 theregistration terminates. Failure
to
adhere to the 90 days
requirement may result indisruption of continued validity
of registration
Application for renewal of registration of a drug shall be
made
in Form 5B.
An application for the renewal of registration shall not
beentertained unless it has been made within sixty days after
the
expiry of the registration.
4.Same amount is paid for
renewal
Rupees two hundred and fifty for the renewal of the
registration of a new or any other drug
5.Certificate of registration is
renewed every year.
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
atime
6.The Registration Certificate(Form II) will be issued only
when the acknowledgement of
receipt of payments is submitted.
A certificate of registration of drug shall be issuedin Form
6.
7.Premises shall be so inspected
by one or more officers oremployees duly designated by
the Secretary, or by persons
accredited to conductinspections.
The Registration Board may, before issuing a
registration], cause the premises in which the manufacture
isproposed to be conducted to be inspected by itself or by its
sub-
committee or by a panel of Inspectors or experts appointed
by
it for the purpose, which may examine all portions of
thepremises 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 theprofessional
qualifications of the technical staff employed
8. The following kind of drugsamples are normally required.
-
Drug samples the quantity of
which is sufficient for clinicaltrial (20g) on sixty patients..
For
certain rare diseases fewer
numbers of samples may be
acceptable. - Samples forlaboratory analysis etc.
Drug sampling is not required unless or until safety,
efficacyand quality of new drug isnt compromised
9. If it is an application forregistration of drugs
manufactured outside of USA.
The Food and Drug
The Registration Board shall, before registering a new drug
forwhich 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,
