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MINISTRY OF HEALTH
ADMINSITRATION OF SCIENCE TECHNOLOGY AND TRAINING
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SOCIALIST
REPUBLIC OF VIETNAM
Independence – Freedom – Happiness
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No. 51/QD-K2DT
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Hanoi, April 17,
2019
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DECISION
ISSUING “GUIDELINES
FOR MANAGING INVESTIGATIONAL DRUGS IN CLINICAL TRIALS IN VIETNAM”
DIRECTOR OF THE ADMINISTRATION OF SCIENCE TECHNOLOGY
AND TRAINING
Decision No. 1388/QD-BYT dated February 22, 2018
of the Minister of Health on functions, powers, and organizational structure of
the Administration of Science Technology and Training affiliated to Ministry of
Health;
Pursuant to Circular No. 29/2018/TT-BYT dated
October 29, 2018 of the Minister of Health on Clinical Trials;
Pursuant to Circular No. 36/2018/TT-BYT dated
November 22, 2018 of Minister of Health on Good preservation practice of drug
and pharmaceutical starting material;
At request of Director of Department of Science
and Technology,
HEREBY DECIDES:
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Article 2. The “Guidelines for managing
investigational drugs in clinical trials in Vietnam” attached hereto are
applied in relevant entities, organizations, and individuals.
Based on this document and specific local
condition, heads of agencies, organizations, and relevant entities shall
develop and promulgate their own Guidelines for managing investigational drugs
accordingly.
Article 3. This Decision comes into effect
from the day of signing.
Article 4. Heads of the Department, Chief
Office of the Department, heads of departments and entities affiliated to the
Department, and heads of relevant entities are responsible for the
implementation of this Decision./.
PP. DIRECTOR
VICE DIRECTOR INCHARGE
Nguyen Ngo Quang
GUIDELINES
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1. Requirements
for investigational drugs
Sponsors must ensure that investigational drugs
(including drug for comparison, and placebo, if any) must:
- Be produced in accordance
with Good Manufacturing Practice (GMP).
- Be encrypted and labeled to
prevent identification (if any).
- Contain the phrase “Thuốc
dùng cho thử lâm sàng, cấm dùng cho mục đích khác” (Drug for clinical trial
purposes only) on the label.
- Be packaged to prevent
contamination and damage during transportation and storage.
2. Management
of investigational drug at sponsors
Sponsors are responsible for maintaining:
a) Documents on preservation, delivery, handling,
recall, and destruction of investigational drugs.
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c) Channels for storing unused investigational
drugs.
d) Stability of investigational drugs throughout
useful life.
e) Sufficient number of investigational drugs to
re-verify their technical specifications, if needed.
3. Provision
of investigational drugs and relevant documents
Sponsors must promptly provide investigators and
principal researchers:
a) Investigational drugs after obtaining approval
of the National Independent Ethics Committee and decision of the Ministry of
Health approving research outline.
b) Documents proving quality of investigational
drug batches used in clinical trials, including batch release certificates,
certificate of quality control, proof of temperature preservation during
transportation.
c) Procedures and guidelines regarding:
preservation temperature, preservation conditions (e.g. avoid sunlight),
arrangement requirements, duration of storage, blending (procedures and
reconstitution solution, etc.), equipment for product infusion (if any),
distribution, recall of unused products from test subjects, return of unused
investigational drugs for sponsors, and destruction of investigational drugs.
d) Mechanism that allows instant unblinding in case
of emergency without breaking blinding code of other test subjects (for blinded
study).
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While preserving investigational drugs,
investigators must be responsible for:
a) Assigning adequate officials to preserve
investigational drugs, assign pharmacists in writing to preserve
investigational drugs during clinical trials.
b) Establishing, promulgating, and implementing
standard preservation practice for investigational drugs.
c) Ensuring facility and equipment requirements for
preserving investigational drugs.
d) Installing preservation areas of investigational
drugs separately with limited access and satisfying temperature, humidity,
lighting, area, and volume requirements to preserve investigational drugs.
e) Preparing adequate means to preserve the
necessary amount of investigational drugs for each stage of clinical trials
while taking into account necessary gaps when arranging investigational drugs.
f) Preparing separate means to preserve
investigational drugs or adopting measures to prevent confusion, risks to
investigational drugs when preserving with other products.
g) Preparing instruments to monitor preservation
temperature and inspecting, recording temperature on a regular basis according
to guidance of sponsors.
h) Adopting measures for preventing unauthorized
access to investigational drugs in order to prevent illegal use of products
(such as using lockable storage, always locking the doors properly), and only
allow researchers to access.
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5. Transportation
of investigational products
During transportation of investigational drugs,
investigators and principal researchers must:
a) Comply with standard transportation practice for
clinical trial drugs.
b) Monitor temperature during transportation and
record the following information as proof of temperature during transportation:
- Identifying details of
containers
- Route: departure and arrival
- Date and time of
transportation
- Quantity or code of
transported investigation drugs (if any)
- Temperature in container and
recording hour of temperature
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d) Prepare backup containers in case of prolonged
transportation.
6. Recall
of investigational products
6.1. Active recall of investigational drugs
Principal researchers are responsible for recalling
unused drugs from test subjects, recalling defective drugs, recalling expired
drugs, recalling drugs that have completed trials, and returning unused
investigational drugs to sponsors.
Sponsors are responsible for maintaining a channel
to recall investigational drugs and keep documents on recall of investigational
drugs.
Recalled investigational drugs must be preserved in
isolated areas.
When investigational drugs are returned to
sponsors, the following information must be specified:
- Date of return
- Name of research
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- Number of batch
- Number of investigational
drugs returned
- Number of investigational
drugs left at the end
- Name of pharmacists
returning the drugs
- Name of individuals or
sponsors receiving returned drugs
6.2. Recall of investigational drugs at request
of GCP inspectorates
Chiefs of the GCP inspectorates of management
authorities have the right to request a recall of research products that do not
guarantee safety for consumers. This request must be recorded in the GCP
inspection record together with the reason.
Within 3 days from the date on which written request
for recall is received, investigators are responsible for recalling
investigational drugs at request of GCP inspectorates and reporting recall
results to the Administration of Science Technology and Training.
Within 30 days from the date on which written
request for recall is received, facilities where drugs are recalled are
responsible for submitting documents to the Administration of Science
Technology and Training together with procedures for rectification;
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In case additional information or clarification of
information relating to the rectification is required, within 30 days from the
date on which documents of Administration of Science Technology and Training
are received, the facilities must submit additional documents and/or provide
explanation. If the facilities fail to submit additional documents and/or
provide explanation before the aforementioned deadline, the rectification
request is no longer valid.
7. Destruction
of investigational drugs
7.1. General requirements
Prior to sending any investigational drugs for
destruction, quantity of destroyed products must be recorded, presented, and
cross-checked for specific clinical trials.
The destruction of investigational drugs shall only
be carried out after any discrepancy regarding quantity of drugs delivered,
received, used, and recalled has been inspected and properly explained and all
cross-checks have been approved by sponsors.
The destruction of investigational drugs must be
safe for humans, animals, environmentally friendly, and compliant with
regulations and law on environmental protection;
Radioactive drugs and packages that have made
contact with radioactive drugs when left unused must be preserved and kept
temporarily before destruction in accordance with regulations and law on atomic
energy.
Radioactive wastes must be managed in accordance
with regulations and law on atomic energy.
If investigational drugs are sent to authorized
entities for destruction, the investigational drugs must be contained in
appropriate containers. Containers must be sealed/covered and labeled to await
destruction.
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Documents recording the destruction of
investigational drugs must be produced and kept. Documents on destruction of
investigational drugs must identify:
- Destruction methods
- Time of destruction
- Description of
investigational drugs (Name, content, and package contents)
- Batch number and expiry date
- Number of test subjects
(upon requested)
- Number of drugs destroyed
- Date of provision
Documents must be signed, specified date by
individuals sending investigational drugs for destruction and verified by
another member of pharmaceutical management team.
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Within 5 working days from the date on which
written request of chiefs of the GCP inspectorates is received, Director of the
Administration of Science Technology and Training has the right to issue
decision on destruction of investigational drugs that can pose serious harm to
health or lives of consumers or commit unrecoverable violations and state
reasons.
Heads of investigators shall issue decision to
establish the Council for destruction of investigational drugs. The Council
must have at least 3 members, 1 of which is responsible for managing research
activities and one other represents the research teams;
Within 6 months from the date on which decision on
destruction of investigational drugs is issued by Administration of Science
Technology and Training, investigators must destroy drugs and submit reports on
destruction results and record of destruction results to Administration of
Science Technology and Training.
7.3. Destruction of investigational drugs at
request of sponsors
Sponsors are responsible for destroying
investigational drugs that are no longer of use for clinical trials.
Sponsors may request destruction of investigational
drugs at the research sites.
If investigators carry out destruction of
investigational drugs, they must first obtain written consent of sponsors.
The destruction of investigational drugs shall only
be implemented after the Administration of Science Technology and Training has
issued written consent.
Within 6 months from the date on which written
consent of Administration of Science Technology and Training is issued,
sponsors are responsible for destroying investigational drugs and reporting to
Administration of Science Technology and Training.