Introduction of FDA's Considerations for Use of Histopathology and Its Associated Methodologies to Support Biomarker Qualification Guidance for Industry / 药物评价研究

FDA issued Considerations for Use of Histopathology and Its Associated Methodologies to Support Biomarker Qualification Guidance for Industry in May 2016.The guideline outlined the characteristics of nonclinical biomarker of histopathology,and explained the scientific standards for the use of histopathological methods in the nonclinical biomarker qualification.This paper introduces the main contents of the guideline,and it is expected to be helpful to the research and supervision in our country.

Requirements for research and labeling of systemic antimicrobial drug microbiology by FDA / 药物评价研究

FDA in August 2016 released Microbiology Data for Systemic Antibacterial Drugs —— Development,Analysis,and Presentation Guidance for Industry,which introduced requirements of the whole process of the research on the microbiology of systemic antimicrobial drugs by FDA.Therefore,the guidance of FDA has an important reference value for the research and supervision of the systemic antimicrobial drugs in our country.The following are particularly noteworthy:requirements for the in vitro AST methods,the QC parameters and the AST interpretive criteria;Requirements for the format and content of the labeling microbiology portion;requirements for periodic evaluation and update of the in vitro AST methods,the QC parameters,and the AST interpretive criteria in postmarketing labeling;Requirements for the number of isolates and the characteristics of pathogenic bacteria for in vitro sensitivity test.

Introduction to DHCP letter format and content guidance recently issued by FDA / 药物评价研究

Dear Health Care Provider (DHCP) letters promptly are directed to doctors and other demanders by manufacturer or FDA to communicate change of description drug labeling,which are divided into three types-Important Drug Warning Letters,Important Prescribing Information Letters,and Important Correction of Drug Information Letters.FDA issued Guidance for Industry and FDA Staff Dear Health Care Provider Letters:Improving Communication of Important Safety Information in February 2017,described in detail the contents and format of the three letters;and listed the models.This paper introduces the main contents of the guidance.Call on China's pharmaceutical production enterprises and regulatory agency from the FDA experience establish the corresponding mechanism in line with China's national conditions,so that doctors and other demanders can be timely access to important new information of labeling to ensure clinical safe and effective medication.

FDA's requirements for clinical pharmacology section of prescription drug labeling / 药物评价研究

FDA issued the Clinical Pharmacology Section of Labeling for Human Prescription Drug and Biological Products — Content and Format Guidance for Industry (final guidance)in December 2016.The Guidance stipulated that clinical pharmacology section must contain three subsections—echanism of action,pharmacodynamics,and pharmacokinetics;If necessary,it can be added to microbiology and pharmacogenomics subsections etc.,as well as explained that the contents of each subsection should be included,also discussed the writing general principles and the format of the section.This paper introduces the main contents of the guidance,with the hope of helping writing and supervision on our country labeling.

Requirements of FDA for biosimilarity studies of clinical pharmacology of biosimilars / 药物评价研究

FDA released Clinical Pharmacology Data to Support a Demonstration of Biosimilarity to a Reference Product Guidance for Industry in December,2016.The guidance describes the requirements of the trial designs and trial methods for the biosimilar clinical pharmacological studies,and especially points out the problems that should be paid special attention to in the studies.However there is no similar guidance in China.This paper introduces the guidance of FDA,which is beneficial to the research and regulation in China.

Introduction to EU's Guideline on the assessment of clinical safety and efficacy in the preparation of European Union herbal monographs for well-established and traditional herbal medicinal products / 药物评价研究

The European Union released Guideline on the assessment of clinical safety and efficacy in the preparation of European Union herbal monographs for well-established and traditional herbal medicinalproducts rev.1 in July 2016.It is noteworthy in the guideline that the test data can be replaced by the literature when the herbal medicine products are applied for registration and according to the scientific strength of the literature,different indications can be approved.This paper introduces the main contents of the guideline and is expected to inspire the research and supervision of Chinese materia medica and phytomedicine in China.