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1.
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Notifying
Member: PHILIPPINES
If applicable, name of local government involved (Article 3.2 and
7.2):
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2.
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Agency
responsible:
Field Regulatory Operations Office
Food and Drug Administration
Department of Health
Name and address (including telephone and fax numbers, email and
website addresses, if available) of agency or authority designated to handle
comments regarding the notification shall be indicated if different from
above:
DR. ZAMUEL A. ZACATE
Director-General
Food and Drug Administration
DR. OSCAR G. GUTTIERREZ, JR. MPA.
Deputy Director General
Field Regulatory Operations Office
Food and Drug Administration
Email: oddgfroo@fda.gov.ph; BPS@dti.gov.ph; BPS.SMD@dti.gov.ph
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3.
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Notified
under Article 2.9.2 [X], 2.10.1 [ ], 5.6.2 [ ], 5.7.1 [ ], 3.2 [ ], 7.2 [ ],
other:
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4.
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Products
covered (HS or CCCN where applicable, otherwise national tariff heading. ICS
numbers may be provided in addition, where applicable): Pharmaceutics (ICS code(s): 11.120)
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5.
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Title,
number of pages and language(s) of the notified document: FDA Circular No. ____ Subject: Guidelines on the
Classification of Deficiencies Observed During Inspection of the Conduct of
Clinical Trials; (4 page(s), in English)
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6.
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Description
of content: These
guidelines shall apply to Sponsors, Clinical Research Organizations (CROs),
Investigators, and Research Ethics Committees (RECs), and other stakeholders
involved in the approval, conduct, monitoring and inspection, in all phases
of clinical trials for Investigational Pharmaceutical Products to ensure that
the rights, safety, and well-being of study subjects have been protected, to
ensure integrity of the scientific data collected and to assess adherence to
the International Council on Harmonization of Good Clinical Practices
(ICH-GCP) Principles.
These guidelines shall also apply to Good Clinical Practice (GCP)
inspectorate service of the FDA's Field Regulatory Operations Office (FROO)
for uniformity of regulatory understanding and implementation of the
classification of deficiencies/non-conformances observed in the conduct of
inspection of the different phases of a clinical trial for investigational
products. And to establish a consistent understanding of the compliance
requirements for all stakeholders, as prescribed by R.A. No. 3720, as amended
by R.A. No. 9711, R.A. No. 11032, A.O. 2020-0010, and pertinent national and
international standards and policies.
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7.
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Objective
and rationale, including the nature of urgent problems where applicable: This Circular is issued to provide uniform
understanding in the classification of noted non-conformances during
inspection of Sponsors, Clinical Research Organizations (CROs),
Investigators, and Research Ethics Committees (RECs), on Good Clinical
Practice (GCP) inspection being performed by the inspectorate service of
FDA's Field Regulatory Operations Office.
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8.
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Relevant
documents:
·_
Administrative
Order 2020-0010 "Regulations on the Conduct of Clinical Trials for
Investigational Products"
·_
FDA Circular
No. 2013-018 "Adoption of the International Conference on Harmonization
(ICH) Safety and Efficacy Guidelines"
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9.
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Proposed
date of adoption: 15
July 2024
Proposed date of entry into force: 15 August 2024
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10.
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Final
date for comments: 15
June 2024
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11.
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Texts available from: National enquiry
point [X] or address, telephone and fax numbers and email and website
addresses, if available, of other body:
Mr. Neil P. Catajay
Director
Bureau of Philippine Standards
Department of Trade and
Industry
3F Trade and Industry Building
361 Sen. Gil Puyat Avenue
Makati City
Philippines
1200
Tel: (632) 751 4700; (632)
7913128
Email: bps@dti.gov.ph
Website: http://www.bps.dti.gov.ph
https://members.wto.org/crnattachments/2024/TBT/PHL/24_03520_01_e.pdf
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