Government simplifies drug registration
Government simplifies drug registration
JAKARTA (JP): Indonesians will be able to obtain new drugs in
a relatively shorter time now than in the past after the
enactment on Monday of a ministerial decree to speed up the
registration process.
"People have the right to obtain new drugs within a short time
without abandoning quality," Minister of Health Achmad Sujudi
said in a speech during a ceremony marking the start of the
integrated drug registration program here.
With the new decree, the registration process for new drugs
will take between 80 and 300 workdays.
The drugs to be evaluated for registration comprise both new
and "copy" drugs. New drugs include newly discovered medicines
and drugs. Copy drugs are drugs which have the same basic content
as those already on the market, such as generic drugs.
New drugs used to treat serious illnesses are evaluated for
registration within 100 workdays. Drugs which in Indonesia are
considered new, but have already been distributed in at least one
other country which has a good evaluation system, are evaluated
for registration within 150 workdays. Other new drugs are
evaluated within 300 workdays.
Generic drugs are examined within 100 workdays, nongeneric
copy drugs within 150 workdays, and drugs especially produced for
export are evaluated within 80 workdays.
During the given time, the drugs are scrutinized by the
national commission for the evaluation of ready-made drugs
(Komnas POJ) which comprise health and pharmaceutical experts and
scholars from the University of Indonesia, Gadjah Mada
University, Bandung Institute of Technology and Airlangga
University.
Anthony Sunarjo, chairman of the Association of Indonesian
Pharmaceutical Companies (GP Farmasi), said that in the past
registration could take as long as two years.
"The new decree will provide a definite time frame for us to
plan production and marketing," he said.
To further speed up the process, copy drugs can now be
registered using computers.
Hardware and software for such purposes is available through
GP-Farmasi. (10)