On 4 August 2016, the Food and Drug Supervisory Agency (Badan Pengawas Obat dan Makanan or BPOM) enacted a new regulation which changes the registration process of drugs.
The changes are reflected in Head of BPOM Regulation No. 17 of 2016 on the Second Amendment of Head of BPOM Regulation No. HK.03.1.23.10.11.08481 of 2011 on the Criteria and Procedures for Drugs Registration (Regulation 17). We will refer to the amended regulation as "Regulation 3".
General Concept of Drugs Registration
Before we look further at the changes in Regulation 17, it is important to know the general concept of the drugs registration regime under Regulation 3.
There are 3 types of drugs registration under Article 5 (1) of Regulation 3:
(a) New Registration: Registration of new drugs which do not have marketing authorization. Based on Article 5 (2) of the Drug Registration Regulations, the type of New Registration is further divided into these categories:
i. Category 1: Registration of New Drugs1 , Biological Products2 , including Similar Biotherapeutic Product3.
ii. Category 2: Registration of Copy Drugs4.
iii. Category 3: Registration of other supplies which contain drugs.
(b) Variation Registration: Registration of change in any aspect of a registered drugs which has marketing authorization, including but not limited to change of formula, method and process of manufacturing, specification for drugs and raw material, packaging and labeling. Based on Article 5 (3) of the Drug Registration Regulations, the type of Variation Registration is further divided into these categories:
i. Category 4: Registration of major changes of the registered drugs' information (i.e., Variation Registration which has meaningful impact on the efficacy, safety and/or quality of the drugs) (variasi major or VaMa).
ii. Category 5: Registration of minor changes of the registered drugs' information which still requires approval, i.e., Variation Registration which cannot be categorized under VaMi-A or VaMa (variasi minor yang memerlukan persetujuan or VaMi-B).
iii. Category 6: Registration of minor variation on drugs which only need to be notified to BPOM, i.e., Variation Registration which has minimal impact or none at all to the efficacy, safety and/or quality of the drugs, and does not change the information in the marketing authorization (variasi minor dengan notifikasi or VaMi-A)
(c) Re-Registration: Renewal or extension of marketing authorization period. Based on Article 5 (4) of the Drug Registration Regulations, Re-Registration is considered as a Category 7 registration.
Amendments in Regulation 17 are mainly focused on improving the process of drugs registration to BPOM.
There are 3 changes under Regulation 17 which generally accommodate a faster and simpler drugs registration process.
The first change made by Regulation 17 is on Article 30. Under Article 30, Variation Registration for Category 4 will be exempted from the pre-registration process.
However, the exception for Category 4 is only applicable for the change of quality of a registered drug that does not need to be proven by clinical trials (uji klinik).
A pre-registration process is provided under Article 28 and it is basically a step in the process of drugs registration which is required by BPOM to:
(a) conduct 'screening' on the drugs registration;
(b) decide the category of registration;
(c) decide the type of evaluation process;
(d) decide the cost of evaluation;
(e) decide the registration document.
The pre-registration process involves submitting supporting documents and undergoing a process which may be time consuming.
In Regulation 3, Article 30 deals with the exemption to the ‘pre-registration’ process for Category 5 and Category 6 of Variation Registration and Re-Registration.
The exemption from the pre-registration process for the above mentioned categories may be due to the fact that those categories do not result in any ‘significant’ changes to the registered drugs and information in its marketing authorization. BPOM’s priority on supervising drugs products is mainly focused on maintaining the safety of the drugs in the market. Any registration of the changes of registered drugs that could potentially have a big impact on the registered drugs in the market will certainly receive more attention from BPOM. This may be the reason why BPOM seems to refrain from giving Category 4 the pre-registration exemption in Regulation 3.
In line with the above explanation, since Variation Registration for Category 4 only deals with major changes in registered drugs (which is heavily monitored by BPOM), this category consumes a lot of time compared to the other categories that are exempted from the pre-registration process.
The changes in Article 30 brought by Regulation 17 could mean that BPOM is loosening up on the Variation Registration process.
But then again, this might be due to the view that pre-registration is not that crucial when it comes to registration of changes such as drug quality (since the registration process does not grant BPOM any authority to prohibit the changes anyway).
Additional Process for Drug Registration
The second change made by Regulation 17 is on Article 31 which deals with the evaluation process of drugs registration.
Drug registrations are divided into several categories based on the duration of their evaluation process by BPOM.
The duration of the evaluation process will vary based on the complexity of the registration. Simpler registration will be categorized into a faster evaluation process by BPOM, and vice versa.
The fastest evaluation process available under Regulation 3 is the '40 days evaluation process' category. This category is reserved for VaMi-B registration and registration of Certificates of Pharmaceutical Products for exported products.
The longest evaluation process available under Regulation 3 is the '300 days evaluation process' category. This category is reserved for Category 1 registration (registration of New Drugs, Biological Products, including Similar Biotherapeutic Products), and VaMa for new indications or new posology which is not included in other evaluation process categories.
Regulation 17 introduce new types of evaluation process for drug registration in addition to the ones previously provided under Regulation 3, as well as minor revisions to the remaining evaluation processes.
The major change in Article 31 of Regulation 17 is the introduction of 2 new evaluation processes:
(a) A 7-day evaluation process is now available for the purpose of applications for exported drugs. In Regulation 3, applications for registration of exported drugs can only be done through a 40-day evaluation process. This is a significant decrease and means a much faster registration process for exported drugs.
b) The new 10-day evaluation process is now introduced for Re-Registration that does not result in any changes to the information or marketing authorization of a drug. This was not accommodated before in Regulation 3, and this means that clients that want to simply re-register their marketing authorization for extension purposes will be able to do so in only 10 days.
Regulation 17 also limits the scope of New Registration of Copy Drugs that can be registered in Indonesia. Previously Regulation 3 allowed the New Registration of all essential generic Copy Drugs under the 100 days evaluation process category. Under Regulation 17, we can now only register (i.e., through New Registration) new essential generic Copy Drugs which are specifically designated for social healthcare programs.
Regulation 17 also requires New Registration for Copy Drugs to also include ‘Stinel’ or an electronic information standard consisting of complete information on drugs, efficacy, safety, use instruction, and other information that must be included in drugs. In other words, the government seems to be insisting that Copy Drugs always be supported with complete information.
Faster Registration Process for Minor Changes on Drugs Information
The third change made by Regulation 17 is on Article 35. Article 35 deals with VaMi-A registration (i.e., registration of minor changes in the registered drugs).
Previously in Regulation 3, the minor changes under VaMi-A registration could be carried out starting from the date when the applicant submits the supporting Variation Registration documents.
Under Regulation 17, BPOM allows the applicant to immediately implement the minor changes in the drugs (i.e., the changes can be done in parallel with the application), but the applicant must report to BPOM on the progress of the changes every 6 months consecutively for all of the changes.
The new monitoring mechanism for changes in drugs is also being introduced in Regulation 17 for minor variation changes.
BPOM has made extensive changes to Appendix XV.B.3, which deals with VaMi registration. All of the changes are focused on making the process simpler and more straightforward.
Due to this change, applicants will not need to go through the hassle of collecting and submitting the supporting documents for non-essential changes in the applicant's registered drugs and can quickly implement the changes into their products.
1 Drug with new active ingredient, new additional ingredient, new form of preparations or drug administration, new potency, or new combination which have not been approved before in Indonesia.
2 Vaccine, immunosera, antigen, hormone, enzyme, blood products and other products resulting from fermentation (including monoclonal antibody and products resulting from the DNA recombinant technology).
3 Biological Products with similar profile of efficacy, safety, and quality to an approved Biological Product.
4 Drugs which contain active ingredients with the same composition, potency, form of preparations, method of administration, indication and posology with an approved drug.