Gaining Market Authorisation (MA)

Question 1

Investigational new drug (IND) application

Answer 1

This is an evaluation of what has been discovered/ tests performed, and the plan for the future regarding a potential new drug. It contains:
* Cover sheet (Form FDA-1571)
* Table of contents
* Part A – Introductory statement and general investigational plan
* Part B – Protocols
* Part C – Chemistry, manufacturing and control information
* Part D – Pharmacology and toxicology information
* Part E – Previous human experience with the investigational drug
* Part F – Additional information

Question 2

Evidence is reviewed by the FDA/ MHRA, by 4 different panels.

Answer 2

• The medical panel looks at the plan for the clinical trials
• The chemistry panel looks at manufacturing and quality assurance for example
• The pharmacology/toxicology panel looks at preclinical
• The statistical panel looks at the accuracy of the protocols and to make sure the plan meets the requirements for the hypothesis, whether the sample size is big enough

Question 3

A safety review is conducted

Answer 3

which indicates the risk if a clinical trial was to be formed. If there is no risk, you can continue the study. If there is a risk, amendments need to be made and the sponsor needs to submit new data

Question 4

New drug application (NDA)

Answer 4

This is the final piece of evidence that is submitted before the drug is brought to market. It is also known as the common technical document.

Question 5

• Module 2 – SUMMARIES

Answer 5

o Critical discussions and assessments
o Abbreviated factual data

Question 6

• Module 3 – QUALITY

Answer 6

o International Non-proprietary Name (INN) selected
o Structural, physical & chemical properties determined
o Stability tested

Question 7

• Module 4 – NON-CLINICAL INFORMATION

Answer 7

o Pharmacology
o Pharmacokinetics (ADME)
o Pharmacodynamics (Drug target)
o Toxicology

Question 8

• Module 5 – CLINICAL INFORMATION

Answer 8

o Biopharmaceutical studies
o Efficacy & safety reports