Romania - Good Clinical Practice (anexa_OMSP_904_2006)
NORMS RELATING TO THE IMPLEMENTATION OF GOOD CLINICAL PRACTICE IN THE CONDUCT OF CLINICAL TRIALS ON MEDICINAL PRODUCTS FOR HUMAN USE
Anexa OMSP 904 2006
CHAPTER I Introduction
These Rules transpose the Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use.
CHAPTER II General principles
Article 702 (4) of Law no. 95/2006 on the healthcare reform, Title XVII, “The Medicinal Product” requires that applications for authorisation to place a medicinal product on the market should be accompanied by a dossier containing particulars and documents relating to the results of tests and clinical trials carried out on the product, which have to be submitted according to analytical, pharmacotoxicological and clinical norms and protocols in respect of the testing of medicinal products, approved through Minister oh Public Health Order no. 906/2006.
(1) The accepted basis for the conduct of clinical trials in humans is founded in the protection of human rights and the dignity of the human being with regard to the application of biology and medicine, as for instance reflected in the 1996 version of the Helsinki Declaration.
(2) The clinical trial subject's protection is safeguarded through risk assessment based on the results of toxicological experiments prior to any clinical trial, screening by ethics committees and the National Medicines Agency, and rules on the protection of personal data.
(1) Persons who are incapable of giving legal consent to clinical trials should be given special protection.
(2) It is incumbent on the National Medicines Agency to lay down rules to this effect.
(3) Such persons may not be included in clinical trials if the same results can be obtained using persons capable of giving consent.
(4) Normally these persons should be included in clinical trials only when there are grounds for expecting that the administering of the medicinal product would be of direct benefit to the patient, thereby outweighing the risks.
(5) However, there is a need for clinical trials involving children to improve the treatment available to them.