インドネシア製薬関連動向【2016年8月号】


 
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CMP BIMONTHLY  REPORT  NO. 001
August 2016
 
General :
Indonesia’s economy was expected to grow by 5.5% this 2016 fiscal year when it was first published. However, it is reduced to 5.2% just a few weeks ago. The reasons are various but the most important factor is the price of some exporting commodities, mineral oils, etc. that makes the government income from taxes and the like is lower than planned.

To overcome the deficit the government just launched a law called “Tax Amnesty”. The main aims are returning back abroad “paper-investment” home, and a realistic capital statement from middle class up to wealthy society. The penalty varies from 0.5% to 8% depending on the amount, type, and time.
 
Health and Pharma issues :
A fraud arising from some vaccine counterfeit exploded by the end of June. Some 14 – 15 kinds of vaccine mostly imported ones were fake. The government through the Ministry of Health, the Police, and the BPOM (local FDA) has taken appropriate actions to overcome.

Indonesia has got a government owned pharmaceutical-company producing various kinds of vaccine and serum. The products are said to fulfill the local demand as well as exported to at least 130 foreign countries. Apparently, some people choose imported vaccines for their offspring.

A supply shortage of some infusion solutions is said to happen lately, due to the GMP surveillance audit taken recently to one of the leading manufacturers.
 
Law and Regulations :
A  BPOM (local FDA) regulation no. 17 / 2016 was issued and immediately enacted on 4th August 2016. This is to succeed regulation no. HK.03.1.23.10.11.0841/2011 on the criterion and route of drug registration.

In principle it announces the following routes of registration.
 
1. Route 7 days for drugs for export market only
2. Route 10 days for re-registration without change
3. Route 40 days for registration with minor variations that needs approval
4. Route 100 days for registration of new drug product and biological product indicated for serious diseases, orphan drug product; new generic product copy intended for community health, completed with supporting data as essential drug; new drug registration that the research and clinical studies performed solely in Indonesia; registration of a drug with new major indication / new posology; and other registration of drug with major variation
5. Route 150 days for registration of new drug and biological product that has been approved by a state with harmonized evaluation system; and registration of a new drug-copy
6. Route 300 days for registration of new product that is not part of route no. 4 or 5 above.

  ● Day = working day, 5 days in a week.
  
  Jakarta 31st August 2016.

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