DECISION

ISSUING “GUIDELINES\r\nFOR MANAGING INVESTIGATIONAL DRUGS IN CLINICAL TRIALS IN VIETNAM”

DIRECTOR OF THE ADMINISTRATION OF SCIENCE TECHNOLOGY\r\nAND TRAINING

Decision No. 1388/QD-BYT dated February 22, 2018\r\nof the Minister of Health on functions, powers, and organizational structure of\r\nthe Administration of Science Technology and Training affiliated to Ministry of\r\nHealth;

Pursuant to Circular No. 29/2018/TT-BYT dated\r\nOctober 29, 2018 of the Minister of Health on Clinical Trials;

Pursuant to Circular No. 36/2018/TT-BYT dated\r\nNovember 22, 2018 of Minister of Health on Good preservation practice of drug\r\nand pharmaceutical starting material;

At request of Director of Department of Science\r\nand Technology,

HEREBY DECIDES:

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Article 2. The “Guidelines for managing\r\ninvestigational drugs in clinical trials in Vietnam” attached hereto are\r\napplied in relevant entities, organizations, and individuals.

Based on this document and specific local\r\ncondition, heads of agencies, organizations, and relevant entities shall\r\ndevelop and promulgate their own Guidelines for managing investigational drugs\r\naccordingly.

Article 3. This Decision comes into effect\r\nfrom the day of signing.

Article 4. Heads of the Department, Chief\r\nOffice of the Department, heads of departments and entities affiliated to the\r\nDepartment, and heads of relevant entities are responsible for the\r\nimplementation of this Decision./.

PP. DIRECTOR
\r\n VICE DIRECTOR INCHARGE
\r\n
\r\n
\r\n
\r\n
\r\n Nguyen Ngo Quang

GUIDELINES

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1. Requirements\r\nfor investigational drugs

Sponsors must ensure that investigational drugs\r\n(including drug for comparison, and placebo, if any) must:

- Be produced in accordance\r\nwith Good Manufacturing Practice (GMP).

- Be encrypted and labeled to\r\nprevent identification (if any).

- Contain the phrase “Thuốc\r\ndùng cho thử lâm sàng, cấm dùng cho mục đích khác” (Drug for clinical trial\r\npurposes only) on the label.

- Be packaged to prevent\r\ncontamination and damage during transportation and storage.

2. Management\r\nof investigational drug at sponsors

Sponsors are responsible for maintaining:

a) Documents on preservation, delivery, handling,\r\nrecall, and destruction of investigational drugs.

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c) Channels for storing unused investigational\r\ndrugs.

d) Stability of investigational drugs throughout\r\nuseful life.

e) Sufficient number of investigational drugs to\r\nre-verify their technical specifications, if needed.

3. Provision\r\nof investigational drugs and relevant documents

Sponsors must promptly provide investigators and\r\nprincipal researchers:

a) Investigational drugs after obtaining approval\r\nof the National Independent Ethics Committee and decision of the Ministry of\r\nHealth approving research outline.

b) Documents proving quality of investigational\r\ndrug batches used in clinical trials, including batch release certificates,\r\ncertificate of quality control, proof of temperature preservation during\r\ntransportation.

c) Procedures and guidelines regarding:\r\npreservation temperature, preservation conditions (e.g. avoid sunlight),\r\narrangement requirements, duration of storage, blending (procedures and\r\nreconstitution solution, etc.), equipment for product infusion (if any),\r\ndistribution, recall of unused products from test subjects, return of unused\r\ninvestigational drugs for sponsors, and destruction of investigational drugs.

d) Mechanism that allows instant unblinding in case\r\nof emergency without breaking blinding code of other test subjects (for blinded\r\nstudy).

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While preserving investigational drugs,\r\ninvestigators must be responsible for:

a) Assigning adequate officials to preserve\r\ninvestigational drugs, assign pharmacists in writing to preserve\r\ninvestigational drugs during clinical trials.

b) Establishing, promulgating, and implementing\r\nstandard preservation practice for investigational drugs.

c) Ensuring facility and equipment requirements for\r\npreserving investigational drugs.

d) Installing preservation areas of investigational\r\ndrugs separately with limited access and satisfying temperature, humidity,\r\nlighting, area, and volume requirements to preserve investigational drugs.

e) Preparing adequate means to preserve the\r\nnecessary amount of investigational drugs for each stage of clinical trials\r\nwhile taking into account necessary gaps when arranging investigational drugs.

f) Preparing separate means to preserve\r\ninvestigational drugs or adopting measures to prevent confusion, risks to\r\ninvestigational drugs when preserving with other products.

g) Preparing instruments to monitor preservation\r\ntemperature and inspecting, recording temperature on a regular basis according\r\nto guidance of sponsors.

h) Adopting measures for preventing unauthorized\r\naccess to investigational drugs in order to prevent illegal use of products\r\n(such as using lockable storage, always locking the doors properly), and only\r\nallow researchers to access.

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5. Transportation\r\nof investigational products

During transportation of investigational drugs,\r\ninvestigators and principal researchers must:

a) Comply with standard transportation practice for\r\nclinical trial drugs.

b) Monitor temperature during transportation and\r\nrecord the following information as proof of temperature during transportation:\r\n

- Identifying details of\r\ncontainers

- Route: departure and arrival\r\n

- Date and time of\r\ntransportation

- Quantity or code of\r\ntransported investigation drugs (if any)

- Temperature in container and\r\nrecording hour of temperature

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d) Prepare backup containers in case of prolonged\r\ntransportation.

6. Recall\r\nof investigational products

6.1. Active recall of investigational drugs

Principal researchers are responsible for recalling\r\nunused drugs from test subjects, recalling defective drugs, recalling expired\r\ndrugs, recalling drugs that have completed trials, and returning unused\r\ninvestigational drugs to sponsors.

Sponsors are responsible for maintaining a channel\r\nto recall investigational drugs and keep documents on recall of investigational\r\ndrugs.

Recalled investigational drugs must be preserved in\r\nisolated areas.

When investigational drugs are returned to\r\nsponsors, the following information must be specified:

- Date of return

- Name of research

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- Number of batch

- Number of investigational\r\ndrugs returned

- Number of investigational\r\ndrugs left at the end

- Name of pharmacists\r\nreturning the drugs

- Name of individuals or\r\nsponsors receiving returned drugs

6.2. Recall of investigational drugs at request\r\nof GCP inspectorates

Chiefs of the GCP inspectorates of management\r\nauthorities have the right to request a recall of research products that do not\r\nguarantee safety for consumers. This request must be recorded in the GCP\r\ninspection record together with the reason.

Within 3 days from the date on which written request\r\nfor recall is received, investigators are responsible for recalling\r\ninvestigational drugs at request of GCP inspectorates and reporting recall\r\nresults to the Administration of Science Technology and Training.

Within 30 days from the date on which written\r\nrequest for recall is received, facilities where drugs are recalled are\r\nresponsible for submitting documents to the Administration of Science\r\nTechnology and Training together with procedures for rectification;

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In case additional information or clarification of\r\ninformation relating to the rectification is required, within 30 days from the\r\ndate on which documents of Administration of Science Technology and Training\r\nare received, the facilities must submit additional documents and/or provide\r\nexplanation. If the facilities fail to submit additional documents and/or\r\nprovide explanation before the aforementioned deadline, the rectification\r\nrequest is no longer valid.

7. Destruction\r\nof investigational drugs

7.1. General requirements

Prior to sending any investigational drugs for\r\ndestruction, quantity of destroyed products must be recorded, presented, and\r\ncross-checked for specific clinical trials.

The destruction of investigational drugs shall only\r\nbe carried out after any discrepancy regarding quantity of drugs delivered,\r\nreceived, used, and recalled has been inspected and properly explained and all\r\ncross-checks have been approved by sponsors.

The destruction of investigational drugs must be\r\nsafe for humans, animals, environmentally friendly, and compliant with\r\nregulations and law on environmental protection;

Radioactive drugs and packages that have made\r\ncontact with radioactive drugs when left unused must be preserved and kept\r\ntemporarily before destruction in accordance with regulations and law on atomic\r\nenergy.

Radioactive wastes must be managed in accordance\r\nwith regulations and law on atomic energy.

If investigational drugs are sent to authorized\r\nentities for destruction, the investigational drugs must be contained in\r\nappropriate containers. Containers must be sealed/covered and labeled to await\r\ndestruction.

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Documents recording the destruction of\r\ninvestigational drugs must be produced and kept. Documents on destruction of\r\ninvestigational drugs must identify:

- Destruction methods

- Time of destruction

- Description of\r\ninvestigational drugs (Name, content, and package contents)

- Batch number and expiry date\r\n

- Number of test subjects\r\n(upon requested)

- Number of drugs destroyed

- Date of provision

Documents must be signed, specified date by\r\nindividuals sending investigational drugs for destruction and verified by\r\nanother member of pharmaceutical management team.

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Within 5 working days from the date on which\r\nwritten request of chiefs of the GCP inspectorates is received, Director of the\r\nAdministration of Science Technology and Training has the right to issue\r\ndecision on destruction of investigational drugs that can pose serious harm to\r\nhealth or lives of consumers or commit unrecoverable violations and state\r\nreasons.

Heads of investigators shall issue decision to\r\nestablish the Council for destruction of investigational drugs. The Council\r\nmust have at least 3 members, 1 of which is responsible for managing research\r\nactivities and one other represents the research teams;

Within 6 months from the date on which decision on\r\ndestruction of investigational drugs is issued by Administration of Science\r\nTechnology and Training, investigators must destroy drugs and submit reports on\r\ndestruction results and record of destruction results to Administration of\r\nScience Technology and Training.

7.3. Destruction of investigational drugs at\r\nrequest of sponsors

Sponsors are responsible for destroying\r\ninvestigational drugs that are no longer of use for clinical trials.

Sponsors may request destruction of investigational\r\ndrugs at the research sites.

If investigators carry out destruction of\r\ninvestigational drugs, they must first obtain written consent of sponsors.

The destruction of investigational drugs shall only\r\nbe implemented after the Administration of Science Technology and Training has\r\nissued written consent.

Within 6 months from the date on which written\r\nconsent of Administration of Science Technology and Training is issued,\r\nsponsors are responsible for destroying investigational drugs and reporting to\r\nAdministration of Science Technology and Training.