Basic principles and examples on which FDA to determine whether firms' medical product communications are consistent with FDA-required labeling / 药物评价研究

FDA issued Medical Product Communications That Are Consistent With FDA-Required Labeling-Questions and Answers Guidance for Industry in January 2017,which introduced basic principles on which FDA to determine whether firms'medical product communications about the use of the product are consistent with the FDA-required labeling (i.e.whether in the allowable range of labeling) and listed examples.This paper introduces the guidance,and is expected to be beneficial to the standardization and supervision of the medical product communications in China.

Introduction of ICH E14 Clinical Evaluation of QT Prolongation Caused by Non-Antiarrhythmic Drug: Q&As (R3) / 药物评价研究

To detect and determine the QT interval prolongation caused by non antiarrhythmic drugs,ICH released the E14 Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs and released E14's questions and answers (ICH E14 Q&As) in 2008 which explained some specific questions.Subsequently,This Q&As were revised third times and in June 2017 forwarded by FDA.The number of questions and answers in the revised edition doubled compared with the original.This article introduces the details of this revised edition,and hopes to be helpful to the research and supervision in China.

Introduction to FDA's Child-Resistant Packaging Statements in Drug Product Labeling Guidance for Industry / 药物评价研究

FDA issued the Child-Resistant Packaging Statements in Drug Product Labeling Guidance for Industry in August 2017,and mainly introduces the requirements for Child-Resistant Packaging Statements in Labeling,and on carton labeling and container labels.However,there is no similar guidance in our country.This paper introduces the guidance in detail,and expects to arise the attention and provide reference of pharmaceutical companies as well as the enlightenment to the administration of drug administration in China.

FDA's requirement for antihypertensive drug labeling increasing content of lowering blood pressure and improving cardiovascular outcomes / 药物评价研究

FDA issued Guidance for Industry Hypertension Indication:Drug Labeling for Cardiovascular Outcome Claims in March 2017,requires that antihypertensive drug labeling should increase the content that lowering blood pressure can prevent serious cardiovascular events,provide a standard description of the INDICATIONS AND USAGE and CLINICAL STUDIES section in labeling in detail.The aim is to encourage the rational use of antihypertensive drugs in hypertensive patients,to reduce blood pressure to the target level,and to improve the outcomes.This paper introduces the main contents of guidance and enumerates a example,and look forward to that antihypertensive drug manufacturers and drug regulatory authorities can learn from this practice of FDA,and work together to revise antihypertensive drug labeling as soon as possible in our country,so as to benefit patients.

Introduction to EMA guideline on therapeutic equivalence studies of generic and reformulated products that are locally applied, locally acting in gastrointestinal tract / 药物评价研究

EMA announced Guideline on equivalence studies for the demonstration of therapeutic equivalence for products that are locally applied,locally acting in the gastrointestinal tract as addendum to the guideline on the clinical requirements for locally applied,locally acting products containing known constituents (Draft) in March 2017,and proposed the general requirements for this equivalence study,introduced the requirements of equivalence studies for drugs acting different parts of the gastrointestinal tract,such as the mouth and/or throat,stomach,intestine and rectum,in detail,which focus on alternative methods of clinical trials-in vitro equivalence tests and PK bioequivalence studies.The guideline is introduced and it is expected to enlighten the trains of thought and methods for efficacy consistency evaluation of such generic and reformulated products in China.

FDA's requirement for antihypertensive drug labeling increasing content of lowering blood pressure and improving cardiovascular outcomes / 药物评价研究

FDA issued Guidance for Industry Hypertension Indication:Drug Labeling for Cardiovascular Outcome Claims in March 2017,requires that antihypertensive drug labeling should increase the content that lowering blood pressure can prevent serious cardiovascular events,provide a standard description of the INDICATIONS AND USAGE and CLINICAL STUDIES section in labeling in detail.The aim is to encourage the rational use of antihypertensive drugs in hypertensive patients,to reduce blood pressure to the target level,and to improve the outcomes.This paper introduces the main contents of guidance and enumerates a example,and look forward to that antihypertensive drug manufacturers and drug regulatory authorities can learn from this practice of FDA,and work together to revise antihypertensive drug labeling as soon as possible in our country,so as to benefit patients.

Introduction to EMA guideline on therapeutic equivalence studies of generic and reformulated products that are locally applied, locally acting in gastrointestinal tract / 药物评价研究

EMA announced Guideline on equivalence studies for the demonstration of therapeutic equivalence for products that are locally applied,locally acting in the gastrointestinal tract as addendum to the guideline on the clinical requirements for locally applied,locally acting products containing known constituents (Draft) in March 2017,and proposed the general requirements for this equivalence study,introduced the requirements of equivalence studies for drugs acting different parts of the gastrointestinal tract,such as the mouth and/or throat,stomach,intestine and rectum,in detail,which focus on alternative methods of clinical trials-in vitro equivalence tests and PK bioequivalence studies.The guideline is introduced and it is expected to enlighten the trains of thought and methods for efficacy consistency evaluation of such generic and reformulated products in China.