Regulatory Reform
ABNR / Indonesia
The ins and outs of regulatory reform in Indonesia. Prepared in association with ABNR, a leading global law firm, this is an extract from The Pharma Legal Handbook: Indonesia, available to purchase here for GBP 99.
1. Are there proposals for reform or significant change to the healthcare systems?
The following proposal for reform may affect the pharmaceutical industry in Indonesia:
Bill on Drugs and Food Supervision Law
The Bill has been submitted by the Indonesian government to the House of Representatives for deliberation. Once approved, the law will serve as an umbrella for regulations on supervision of foods and drugs, which covers a whole range of aspects in the foods and drugs industry, including: production; distribution; export and import; promotion and advertising; laboratory testing, recalls and disposal; liabilities; and criminal sanction.
2. When they are likely to come into force?
It is not clear and difficult to predict on when the new law will come into effect.
The bill on Drugs and Food Supervision Law has been deliberated between the government and the House of Representatives since 2016 and there has been no indication on when the House will approve the bill. The House’s approval is required to enact the law. According to publicly available information on the House’s website, it appears that the bill was last deliberated on 10 March 2020 and there has been no significant progress since then.
