Role of HSA in clinical Trial

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Role of HSA in Clinical Trials
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• HSA
• The Health Sciences Authority (HSA) is a
  multidisciplinary agency in health sciences
  expertise.
• Administer the national regulatory frameworks for
  pharmaceuticals, complementary medicines, medical
  devices and other health products.
• Run the national blood bank and provide of
  transfusion medicine services.
• Provide of forensic medicine expertise,
  investigative forensic and analytical science
  services.

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Formation Regulatory Bodies

• As a statutory board of the Ministry of Health on
  1 April 2001.
• New Organisational structure in 2005

HSA
Health Products Regulation
Applied Sciences
Health Services
Center for Drug Administration
Center for Medical Device Regulation
MCRC
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Centre for Drug Administration (CDA)

• Ensures that medicinal and health-related
  products in Singapore meet appropriate standards
  of safety, quality and efficacy.
• Pre-marketing evaluation of medicinal products,
  includes western medicinal products, Chinese
  proprietary medicines cosmetic products.
• Regulation of clinical trials in Singapore the
  provision of unbiased drug information to health
  professionals and the public
• Administers enforces the Smoking Act in support
  of the Government's efforts to reduce smoking
  promote public health.

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Centre for Drug Administration (CDA)

• Regulates medicinal other health-related
  products under the Medicines Act, the Poisons
  Act, the Sale of Drugs Act, the Medicines
  (Advertisement and Sale) Act the Misuse of Drug
  Regulations. Post-marketing regulatory activities
  include quality surveillance programmes, routine
  inspections and investigations into
  contraventions of legislation.
• The spontaneous reporting of adverse drug
  reactions is also one of the important tools used
  to keep continued vigilance on the safety of all
  marketed drugs in Singapore.
• Inspects and licenses pharmaceutical
  manufacturers and importers/wholesale dealers in
  accordance with current international Good
  Manufacturing Practice (GMP) and Good
  Distribution Practice (GDP) standards.

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SGGCP

• With Increase in clinical research activities in
  Singapore and the need to accord appropriate
  protection to ensure the safety and well-being of
  trial subjects, the CDA reviewed and updated the
  Medicines \ Regulations and implemented the
  Singapore Guideline for Good Clinical Practice
  (SGGCP) on 1 Aug 1998.
• The SGGCP, which was adapted from the
  International Conference on Harmonisation (ICH)
  Guideline for Good Clinical Practice (GCP), sets
  ethical and scientific standards for the conduct
  of clinical trials.

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The Medical Clinical Research Committee (MCRC)

• All clinical trials on medicinal products
  conducted in Singapore requires Clinical Trial
  Certificates (CTC) from the Centre for Drug
  Administration, Health Sciences Authority.
• The Medical Clinical Research Committee (MCRC)
  provides advice on the licensing of clinical drug
  trials.

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The Medical Clinical Research Committee (MCRC)

• The MCRC provides
• New applications for clinical trial certificates
  
• Amendments to clinical trial protocols and
  informed consent documents
• Serious adverse event reports and
• Requests for CTC extension.

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CTC

• Applied Electronically http//eservice.hsa.gov.s
  g/osc/portal/jsp/AA/process1.jsp
• Issues the regulatory approval, in the form of a
  Clinical Trial Certificate (CTC) in the name of
  the principal investigator. It is specific for
  each study protocol, and for each institution or
  site involved in the study.
• Applications for CTC are to be made by the
  sponsor, which should be a locally registered
  company. Only one application is required for
  multi-centre clinical trials on the same drug
  using the same trial protocol to be conducted at
  two or more local institutions.

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Documents to be submitted for CTC

• The following documents shall be submitted to the
  MCRC
• trial protocols
• consent forms
• subject recruitment procedures   written
  information to subjects
• investigators brochure
• available safety information
• information about payment and compensation
  available to subjects.
• investigators CV

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Summary

• The MCRC will help to ensure the safety and
  efficacy of new drugs before they are registered
  in accordance Singapore Good Clinical Practice
  Guidelines. Through its monitoring process, it
  will strive to maintain the highest standards in
  the conduct of clinical trials.
• Clinical drug trials use the newest drug therapy
  which is believed to be safe and efficacious for
  the patient. Benefit to the patient must override
  benefit to science and society.
• NB The trial certificate is valid for 2 years.
  If the trial is not completed at the end of 2
  years, a new application is required.

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