Government simplifies drug registration<\/p>\n
JAKARTA (JP): Indonesians will be able to obtain new drugs in
\na relatively shorter time now than in the past after the
\nenactment on Monday of a ministerial decree to speed up the
\nregistration process.<\/p>\n
\"People have the right to obtain new drugs within a short time
\nwithout abandoning quality,\" Minister of Health Achmad Sujudi
\nsaid in a speech during a ceremony marking the start of the
\nintegrated drug registration program here.<\/p>\n
With the new decree, the registration process for new drugs
\nwill take between 80 and 300 workdays.<\/p>\n
The drugs to be evaluated for registration comprise both new
\nand \"copy\" drugs. New drugs include newly discovered medicines
\nand drugs. Copy drugs are drugs which have the same basic content
\nas those already on the market, such as generic drugs.<\/p>\n
New drugs used to treat serious illnesses are evaluated for
\nregistration within 100 workdays. Drugs which in Indonesia are
\nconsidered new, but have already been distributed in at least one
\nother country which has a good evaluation system, are evaluated
\nfor registration within 150 workdays. Other new drugs are
\nevaluated within 300 workdays.<\/p>\n
Generic drugs are examined within 100 workdays, nongeneric
\ncopy drugs within 150 workdays, and drugs especially produced for
\nexport are evaluated within 80 workdays.<\/p>\n
During the given time, the drugs are scrutinized by the
\nnational commission for the evaluation of ready-made drugs
\n(Komnas POJ) which comprise health and pharmaceutical experts and
\nscholars from the University of Indonesia, Gadjah Mada
\nUniversity, Bandung Institute of Technology and Airlangga
\nUniversity.<\/p>\n
Anthony Sunarjo, chairman of the Association of Indonesian
\nPharmaceutical Companies (GP Farmasi), said that in the past
\nregistration could take as long as two years.<\/p>\n
\"The new decree will provide a definite time frame for us to
\nplan production and marketing,\" he said.<\/p>\n
To further speed up the process, copy drugs can now be
\nregistered using computers.<\/p>\n
Hardware and software for such purposes is available through
\nGP-Farmasi. (10)<\/p>",
"url": "https:\/\/jawawa.id\/newsitem\/government-simplifies-drug-registration-1447893297",
"image": ""
},
"sponsor": "Okusi Associates",
"sponsor_url": "https:\/\/okusiassociates.com"
}