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)