Consider:

a. that in order to accelerate drug availability during public health emergencies, the National Agency
of Drug and Food Control and Food has established provisions regarding (emergency authorization)
as regulated in the Regulation of the Head of the Food and Drug Supervisory Agency Number 24.
Head of the Food and Drug Supervisory Agency Number 24 Year 2017 on Criteria and Procedures for
the Registration of Drugs as amended several times last by Regulation of the Food and Drug
Supervisory Agency Number 27 of 2020 concerning the Second Amendment to Regulation of the
Head of the Food and Drug Administration Number 24 of 2017 concerning Criteria and Procedures
for Drug Registration;

b. that to guarantee the use of drugs during public health emergencies as referred to

in letter a meet the criteria for safety, efficacy, and quality as well as to implement Article 2
paragraph (3) of Regulation Presidential Regulation Number 99 of 2020 concerning Vaccine
Procurement and Implementation of Vaccination in the Context of Overcoming Corona Virus Disease
2019 (COVID-19) Pandemic, it is necessary to stipulate a Decree of the Head of the Food and Drug
Administration Food on Technical Guidelines for the Implementation of (Emergency Use
Authorization);

Considering:

1. In 2018 on Health Quarantine (State Gazette of the Republic of Indonesia 2018 Number 128,
Supplement to State Gazette of the Republic of Indonesia Number 6236);
2. Presidential Regulation No. 80/2017 on the Food and Drug Administration
Food and Drug Administration (State Gazette of the Republic of
Indonesia Year 2017 Number 180);
3. Presidential Regulation Number 99 of 2020 concerning
Vaccine Procurement and Vaccination Implementation in
Context of Combating the Corona Virus Disease 2019 Pandemic
(COVID-19) Pandemic (State Gazette of the Republic of Indonesia
2020 Number 227);
4. Regulation of the Head of the Food and Drug Administration
Number 24 of 2017 concerning Criteria and Procedures for
Drug Registration (State Gazette of the Republic of Indonesia Year
2017 Number 1692) as has been amended several times
last amended by Regulation of the Food and Drug Administration
Food and Drug Administration Regulation Number 27 of 2020 concerning the Second
Amendment
to the Regulation of the Head of the Food and Drug Supervisory Agency
Number 24 of 2017 concerning Criteria and Procedures for
Drug Registration (State Gazette of the Republic of Indonesia Year
2020 Number 1123);
5. Regulation of the Food and Drug Administration Number 21
of 2020 concerning the Organization and Work Procedures of the Food and Drug Monitoring
Agency
Food and Drug Administration (State Gazette of the Republic of
Indonesia Year 2020 Number 1002);
 CONCLUDE

Decide:

DECREE OF THE HEAD OF THE FOOD AND DRUG ADMINISTRATION ON TECHNICAL GUIDELINES FOR
THE IMPLEMENTATION OF (EMERGENCY USE AUTHORIZATION).

First:

Establish and enforce Technical Implementation Guidelines (Emergency Use Authorization)

hereinafter referred to as the Technical Guidelines as listed in the attachment which is an inseparable
part of this Decree.

Second:

Technical Guidelines as referred to in the First dictum, is a guideline for the Food and Drug
Supervisory Agency, business actors in the field of drugs and all stakeholders in the context of
implementing the approval of (emergency use authorization) during conditions of public health
emergencies.

Third:

This Decree shall come into force on the date of its promulgation.

TECHNICAL GUIDELINES

IMPLEMENTATION OF EMERGENCY USE APPROVAL

(EMERGENCY USE AUTHORIZATION)

CHAPTER I

INTRODUCTION

A. BACKGROUND

The Food and Drug Administration (Badan Pengawas Obat dan Makanan, POM) is responsible for
ensuring the safety, efficacy, and quality of all drugs that will be circulated in the territory of
Indonesia. To accelerate drug availability during public health emergencies, including outbreaks of
COVID-19 infectious diseases and in accordance with Presidential Regulation Number 99 of 2020
concerning Vaccine Procurement and Vaccination Implementation in the Context of Combating the
2019 Corona Virus Disease Pandemic (COVID-19) pandemic, the Food and Drug Administration has
stipulated Regulation of the Food and Drug Administration Drugs and Food Number 27 of 2020
concerning the Second Amendment to the regulation of the Head of the Food and Drug
Administration Number 24 Year2017 on Criteria and Procedures for Drug Registration. Regulation of
the Agency POM regulates the granting of (emergency use authorization/EUA) for the use of drugs
during public health emergencies. public health emergencies.

An EUA is an approval for the use of a drug during public health emergencies for drugs that have not
yet been licensed or distribution license or drugs that have obtained a distribution license but with
indication (new indication) for public health emergencies public health emergencies.
The issuance of EUA is given by considering the benefits and safety of patients based on scientific
evidence of the results of the and patient safety based on scientific evidence of clinical trial results
that shows that the drug has potential efficacy and safety, but has limited data, for example in terms
of has data limitations, for example in terms of the adequacy of the number of subjects and the
monitoring period of clinical trials and the clinical trial monitoring period is still limited as well as the
possibility of stability data that still needs to be completed stability data that still needs to be
completed, while to obtain a distribution license these things must be fulfilled to obtain a
distribution license these things must be fulfilled.

B. PURPOSE

This guideline is intended as a technical guide for emergency use authorization (Emergency Use
Authorization/EUA) for internal POM, business actors and related stakeholders, in the context of the
acceleration of drug availability in Indonesia to cope with public health emergencies. public health
emergencies.

C. SCOPE

The scope of the Guidelines covers the criteria/requirements, procedures and implementation of
EUA for drugs, including biological products and vaccines.

CHAPTER II

IMPLEMENTATION

A. Criteria for emergency use approval (Emergency Use Authorization/EUA)

An EUA is an approval for the use of a drug during public health emergencies for drugs that have not
yet been licensed or distribution license or drugs that have obtained a distribution license but with
indication (new indication) for public health emergencies public health emergencies.

EUA can be granted for certain drugs if they meet the following criteria as follows:

1. A public health emergency has been declared by the Government;

2. There is sufficient scientific evidence related to the safety and efficacy aspects of the medicine to
prevent, diagnose, or treat serious and life-threatening diseases/ conditions based on data from the
serious and life-threatening diseases/circumstances based on non-clinical, clinical, and non-clinical,
clinical, and related disease management guidelines;

3. Has quality that meets applicable standards and Good Manufacturing Practices;

4. Has a benefit greater than the risk (risk-benefit analysis) based on a review of non-clinical and
clinical data of the drug for the proposed indication; and

5. There is no alternative treatment/management that is adequate and approved for the diagnosis,
prevention or treatment of diseases causes of public health emergencies.

Drugs that can be submitted for EUA include:

1. Drugs, including biological products required for a public health emergency; or

2. A registered medicine with a new indication and/or posology for a public health emergency public
health emergency.
B. (Emergency Use Authorization/EUA) Procedure

1. The Pharmaceutical Industry submits an application for the issuance of EUA to POM electronically
through the official website of drug registration services drug registration service of the POM Agency
by accessing https://new-aero.pom.go.id

2. Documents required for the application for the issuance of EUA refer to drug registration
requirements as stipulated in Food and Drug Administration regulations governing regarding criteria
and procedures for drug registration. Considering the urgency of drug use in public health
emergencies, flexibility is possible for the safety efficacy and quality documents with the following
provisions:

a. Safety and efficacy data:

1) Drugs:

Non-clinical and clinical data that have demonstrated the potential efficacy and safety of the drug for
the proposed indication

at least in a phase II clinical study with an adequate number of subjects

adequate number of subjects.

2) Vaccine Specific Drugs:

i. non-clinical data demonstrating safety profile, immunogenicity and efficacy, if any, based on the
most appropriate animal model, supported by justification animal models, supported by adequate
justification. If at the time of submission of the EUA the non-clinical data is incomplete, a rational
justification must be provided. non-clinical data is incomplete, a rational and adequate justification
should be provided and adequate justification, as well as the timeframe when the data will be
submitted the data;

ii. Clinical data showing appropriate dosing and acceptable immunogenicity and safety
immunogenicity and safety data that are acceptable to the population that will use the vaccine in a
public health emergency

iii. Specifically for the EUA of vaccine products, the review will be carried out case by case by
considering the target population, characteristics of the product, non-clinical and clinical outcome
data, as well as comprehensive scientific evidence related to the product. in this regard, based on the
scientific evidence from the results of the non-clinical and available preliminary clinical trials,
immunogenicity data can be considered as a potential surrogate for evidence of clinical efficacy.
Example:

a) Non-clinical and clinical data of at least phase 3

(immunogenicity which is predictive of efficacy, and safety) with an adequate number of subjects.
safety) with an adequate number of subjects based on standardized statistical studies and have
completed immunogenicity analysis and / or interim data analysis efficacy and safety data for at least
6 (six) months;

b) Phase III non-clinical and clinical data with a sufficient number of subjects sufficient number of
subjects according to statistical calculations, and have completed immunogenicity analysis and
interim analysis of efficacy and safety data for at least 3 months.
B. Quality data:

1) Pilot-scale accelerated and long-term drug stability of 2 (two) batches for at least 3 (three) months
and stressed study (if necessary) accompanied by a stamped statement letter as a commitment to
submit long-term stability test data until the proposed shelf life.

2) Pilot scale process validation report of 1 (one) batch accompanied by a stamped statement letter
as a commitment to submit the process validation report of the first 3 (three) batches of production
scale along with the predicted time of submission of the validation report with a copy to the
Directorate of Production Supervision of Drugs, Narcotics, Psychotropic Substances and Precursors.

3) If bioequivalence test data is required for generic drugs, comparable dissolution test (UDT) data on
innovator or registered products that have been bioequivalent to innovator products can be
submitted along with a stamped statement as a commitment to conduct bioequivalence tests on
innovator products and a roadmap for the implementation of bioequivalence tests starting from
submitting approval for the implementation of bioequivalence tests to submitting bioequivalence
test reports to the POM Agency.

c. After obtaining EUA approval, the pharmaceutical industry is still obliged to submit the fulfillment
of safety, efficacy and quality documents in accordance with the documents required in the
Regulation of the Food and Drug Administration which regulates the criteria and procedures for drug
registration.

3. Evaluation is carried out on documents on safety, efficacy and quality aspects for drugs, including
biological products that have never received a distribution permit, or safety and efficacy aspects for
drugs, except for biological products that have been registered with the Food and Drug
Administration with new indications.

4. The evaluation is conducted by Badan POM together with the National Committee for Drug
Assessment (KOMNAS) Team by involving relevant clinicians. The evaluation process refers to the
evaluation provisions as stipulated in the Food and Drug Administration Regulation governing drug
registration criteria and procedures. EUA is limited to approved indications in public health
emergencies based on the evaluation results.

5. Based on the recommendations of the National Drug Assessment Team and relevant experts, the
POM will issue an EUA with a special number no later than 20 (twenty) Working Days from the time
the documents are submitted to the POM.

6. EUAs are issued under the following conditions:

a) Approval is granted in accordance with the product information which is an attachment to

the EUA approval in the form of approved Product Information for health workers (Fact
Sheet) and for patients (Product Information for Patients);
b) The POM has the right to review/re-evaluate the efficacy and safety aspects of the drug if
new evidence is found related to the efficacy and safety of the drug; and
c) EUA approval is only valid until the end of the public health emergency period by the
government and will then be reviewed according to the latest developments and conditions.

7. Obligations of the Pharmaceutical Industry with EUA:

a. be responsible for the quality of the drug;

b. conduct clinical studies to ensure the efficacy and safety of the drug as indicated in
the EUA;
 c. conduct pharmacovigilance monitoring and reporting of drug side effects to the
POM; and
d. report the realization of use1) which includes the number, batch number and
expiration date of batches circulated for the implementation of EUA approval to the
Head of the POM.

8. Label Requirements

a. The label on drugs that have been approved by the EUA must comply with the label
requirements as stipulated in the Regulation of the Head of the Food and Drug
Administration which regulates the criteria and procedures for drug registration.
b. In addition to complying with the provisions as referred to in letter a, the label on
the secondary packaging of drugs that have received EUA must also be completed
with the addition of the EUA-specific information.

C. Implementation of (Emergency Use Authorization/EUA)

1. Importation

a. The issued EUA can be used as if it were a distribution license for the importation
process.
b. The importation process of drug ingredients for EUA drugs or EUA drugs is carried
out in accordance with the importation provisions as stipulated in the Regulations of
the Food and Drug Administration governing the importation of drugs and food.
c. For the importation of drugs with EUA, the identity of the Circulation Permit Number
on the Import Certificate is replaced with the EUA letter number.
d. Importers of medicinal materials for EUA drugs or EUA drugs must submit a
notification to the Director of Narcotic Drugs, Psychotropic Substances, Precursors
and Addictive Substances Import Safety, Quality and Export Control regarding the
planned arrival of import realization no later than 3 (three) days before arrival which
is submitted electronically.
e. Importers of drug ingredients for EUA drugs or EUA drugs must submit a report on
the implementation of drug imports no later than 3 (three) days after receipt at the
importer's warehouse.

2. Production

a. Production activities are carried out in accordance with the provisions of laws and
regulations.
b. In addition to the provisions as referred to in letter a, pharmaceutical industry
reporting is also carried out every time a production batch is released and reported
electronically.

3. Distribution

a. Drugs granted an EUA may be distributed within Indonesia in accordance with the
Food and Drug Administration's regulations governing drug registration criteria and
procedures.
 b. Drugs granted EUA can only be distributed strictly to hospitals or health centers
designated to treat patients with diseases that fall under public health emergencies
(e.g. COVID-19).
c. Drug distribution can only be carried out by authorized distributors appointed by the
Pharmaceutical Industry that owns the EUA and has a certificate of Good Drug
Distribution Practices (CDOB) in accordance with the type of drug being distributed.
d. The pharmaceutical industry that owns the EUA must report the distribution of drugs
provided by the EUA to the POM every 2 (two) weeks through an electronic system.
e. Distributors who distribute drugs granted EUA must report the entry and distribution
of such drugs to the NA-DFC with a copy to the pharmaceutical industry that owns
the EUA every 2 (two) weeks through the electronic system.
f. Hospitals or health centers that use drugs granted by the EUA must report the entry
and use of such drugs to the NA-DFC with a copy to the pharmaceutical industry that
owns the EUA every 2 (two) weeks through the electronic system.
g. The pharmaceutical industry that owns the EUA ensures the implementation of
reporting by distributors and hospitals/community health centers.
h. Health workers must provide information about the medicine provided by the EUA
to the patient or his/her family in accordance with the Product Information approved
by the POM.

4. Conducting further clinical trials to confirm the efficacy and safety of the drug.

a. Clinical trials conducted by the pharmaceutical industry for drugs administered by

EUA aim to further confirm the efficacy and safety of the drug in accordance with the
approval granted.
b. Further clinical trials may be conducted in the form of clinical trials abroad or clinical
trials in Indonesia.
c. Clinical trials in Indonesia apply to drugs, including generic drugs, that are granted
EUA in accordance with the provisions of laws and regulations.
d. Clinical trials as referred to in point c) above are experimental and observational
studies conducted based on protocols approved by the POM Agency.
e. The implementation of clinical trials must be carried out immediately after the EUA
is issued. The implementation of clinical trials must fulfill the rules of Good Clinical
Trials (CUKB).
f. The POM will supervise the implementation of clinical trials.
g. For the pharmaceutical industry that owns an EUA that does not conduct clinical
trials, administrative sanctions may be imposed in accordance with the provisions of
laws and regulations.

5. Pharmacovigilance Monitoring

a. The pharmaceutical industry that owns the EUA must actively monitor
pharmacovigilance in accordance with the provisions of laws and regulations in the
field of Pharmacovigilance Implementation for the Pharmaceutical Industry.
b. In addition to the provisions of number 5 letter a, reporting of serious adverse
events in the form of death must be submitted to the POM within 24 (twenty-four)
hours at the latest on the next business day, as an initial report from the time the
pharmaceutical industry becomes aware of the information, and no later than 15
(fifteen) calendar days as a complete follow-up report.
 c. Exempted from the provisions of number 5 letter a, the pharmaceutical industry that
owns the EUA is obliged to periodically report active pharmacovigilance monitoring
to the POM every 1 (one) month.

6. Reassessment

a. The POM may conduct a reassessment of a drug granted an EUA, if there are changes in the latest
data or information regarding the efficacy, safety and quality of the drug based on:

1) the results of clinical trials;

2) results of quality monitoring; and/or
3) pharmacovigilance monitoring results.

b. If based on the results of the reassessment as referred to in letter a, the drug does not
demonstrate the safety, efficacy and quality aspects as approved, the EUA may be revoked.

c. For a revoked drug EUA, it is mandatory to withdraw the drug from circulation in accordance with
the provisions regarding Food and Drug Administration regulations governing the withdrawal and
destruction of drugs that do not meet the standards and/or requirements for safety, efficacy, quality,
and labelling, as a class I drug withdrawal.

D. Transition of Emergency Use Authorization (EUA) to Circulation Permit.

An EUA approval may be converted into a Circulation Permit if it has undergone the drug registration
process and met the requirements through the 100 HK fast track in accordance with the provisions of
the Food and Drug Administration regulations governing drug registration criteria and procedures.