New Regulation on Criteria and Drug Registration Procedure
On 24 November 2017, Food and Drugs Supervisory Agency (Badan Pengawas Obat dan Makanan BPOM) Regulation No. 24 of 2017 on Criteria and Drug Registration Procedure (Regulation 24) was enacted. The government had viewed that the previous regulation had to be adapted to keep up with the latest developments in science and technology. This new regulation revokes Head of the National Agency for Food and Drugs Control Regulation Numbers HK.03.1.23.10.11.08481-2011, 3/2013 and 17/2016 on the same matter.
Implication for Applicants
BPOM intends to cover the registration of more types of drug products in Indonesia with the issuance of Regulation 24. It contains some new provisions that may have an impact on the registration of drugs in Indonesia.
The following are key changes under Regulation 24.
Definition of and registration of Generic Drugs (Obat Generik), Branded Generic Drugs (Obat Generik Bermerek) and First Generic Drugs (Obat Generik Pertama)
BPOM has clearly defined Generic Drugs (Obat Generik), Branded Generic Drugs (Obat Generik Bermerek) and First Generic Drugs (Obat Generik Pertama) in this regulation. Further, it sets out clearly how these products must be registered. For example, First Generic Drugs (Obat Generik Pertama) with active substances that are covered by a patent in Indonesia can be submitted by an applicant who is not the patent legal owner. However, the product registration of these products will only be issued after the expiry of the patent protection.
Exemption from Product Registration Requirement
Drugs that will be circulated in the territory of Indonesia are required to have product registrations. There is an exemption from this requirement for drugs imported for special use. The process for the exemption is set out in other prevailing laws and regulations.
Criteria of Drugs
Regulation 24 provides a new criteria for registration of drugs. Drugs must fulfill, among other things, the required quality standard, including the production process requirements based on a Good Manufacturing Product (Cara Pembuatan Obat yang Baik - CPOB) certificate, which must be supplemented by valid evidence.
Category of Registration
As mentioned above, BPOM tried to cover the registration of more types of drugs. The categories of registration of drugs are amended as follows:
a. Category 1: Registration of New Drugs and Biological Products, including Biosimilar Products
b. Category 2: Registration of Generic Drugs (Obat Generik) and Branded Generic Drugs (Obat Generik Bermerek)
c. Category 3: Registration of other substances containing Drugs with special technology, which can be in the form of transdermal patches, implants and beads
Registration of Drugs under a Manufacturing Contract
Drugs can be manufactured wholly or partially by a third party based on a manufacturing contract. In the previous regulation, there was no requirement for the third party to have a CPOB certificate. In Regulation 24, the third party must have a valid CPOB certificate covering the production of the substance of the drugs that will be produced.
The third party may produce the drugs in more than one production plant but there must be justification for doing so. However, it is not clear what justification or circumstances can be accepted by BPOM. Further clarification from BPOM is needed.
Registration of Imported Drugs
Imported Drug Registration can only be done by the applicant after the applicant obtains a written approval from a foreign pharmaceutical manufacturing company. However, there is an exemption if the applicant is an affiliated company of the foreign pharmaceutical manufacturing company. However, there is no further definition of affiliation. Confirmation of the definition of affiliation from BPOM is needed.
Regulation 24 provides a new requirement that the written approval from the foreign pharmaceutical manufacturing company must contain the term of the cooperation. This requirement is important since the term of the product registration will be the same as the term of the cooperation agreement or letter of appointment.
In addition, Regulation 24 stipulates that drugs prioritized for import are those for public health programs, newly invented drugs and drugs that are required but cannot be manufactured domestically. The "newly invented drugs" consist of drugs that are still protected by patent or originator drugs. Originator drugs are drugs that are firstly registered in Indonesia based on the comprehensive data of
efficacy, safety and quality. However, this kind of drug does not need to be newly innovated as required under the previous regulation.
Further, Regulation 24 does not clarify the term "cannot be manufactured locally", and so it remains to be seen how it will be implemented. How it is implemented will depend on the policy of BPOM, which can change from time to time.
Registration of Drugs under the License Agreement
Under Regulation 24, the licensor in the license agreement must be in the form of (i) a local or foreign pharmaceutical manufacturing company or (ii) the local or foreign research entity that owns the formula and technology. Under the previous regulation, the licensor had to be a foreign pharmaceutical manufacturing company, or a local or foreign research entity that owns the formula and technology. As such, Regulation 24 gives a broader scope by including local pharmaceutical manufacturing companies as parties that can be the licensor.
Registration of Patented Drugs
Applications for registration of products with active substances that are covered by a patent in Indonesia can be submitted by an applicant who is not the patent legal owner. The drugs can be registered from five years prior to the expiration of patent protection.
Registration of Orphan Drugs
Regulation 24 recognizes the registration of Orphan Drugs. However, unfortunately there is no detailed process for the registration of Orphan Drugs. This will be further regulated in another BPOM regulation.
BPOM tried to shorten the evaluation process for certain types of registrations and drugs. The previous regulations only covered 40, 100, 150 or 300-day periods for doing the evaluation process. Regulation 24 provides a shorter period of evaluation of 7 days, but there are still periods of up to 300 days subject to the type of registrations and drugs.
Applications for reregistration can be submitted at the earliest 12 months and at the latest two months before the expiration of the validity period of a distribution permit.
Absence of requirement to conduct real production or distribution
In the previous regulation, there was a requirement for the product registration holder to produce or import and distribute the drugs within one year after the issuance of the product registration. The previous regulation also set out administrative sanctions (ie, freezing or cancelation of the product registration) if the product registration holder did not comply with this requirement.
In Regulation 24, this requirement is removed. However, this provision is also found in another regulation, ie, Minister of Health Regulation No. 1010/MENKES/PER/XI/2008 dated 3 November 2008 on Drug Registration as amended by MOH Regulation No. 1120/MENKES/PER/XII/2008 dated 1 December 2008 ("Regulation 1010"). As such, although this requirement is removed in Regulation 24, the product registration holder still must comply with this requirement under Regulation 1010.
Regulation 24 added a new administrative sanction (ie, a prohibition for registering products for two years) which can be applied in the following circumstances:
a. The drugs do not meet the criteria under Regulation 24
b. The information in the registration documents is not correct and lawful
c. The provided information is not valid