Routes to a new drug application submission

Question 1

what 3 centres is the MHRA formed of

Answer 1

1. clinical practice research datalink (CPRD)
2. National institute for biological standards and control
3. MHRA

Question 2

what are the roles of the FDA

Answer 2

1. development of regulatory policy
2. establishment of regulations and guidance document in support of FDA act
3. review and approval of pre marketing submissions for drugs and devices
4. inspection of facilitates and products
5. ensuring that labelling, packaging and promotional material is truthful and informative
6. participation in international initiatives on global harmonisation

Question 3

what is the CDER responsible for

Answer 3

1. reviewing application for new and generic pharmaceuticals
2. manages US GMP regulations for pharmaceutical manufacturing
3. determines which medications require medical prescription
4. monitors advertising of approved medications
5. collects and analyses safety data about pharmaceuticals already in market

Question 4

what are the roles of the EMA

Answer 4

1. facilitate development and access to medicines
2. evaluate applications for marketing authorisations
3. monitor safety of medicines across their life cycle
4. provide reliable info on human and veterinary medicines

Question 5

when is an IND application required

Answer 5

required if a sponsor intends to conduct a human clinical investigation with an investigational new drug

Question 6

what is discussed in a preIND meeting with a regulator

Answer 6

1. design of animal research, which is required to lend support to clinical studies
2. intended protocol for conducting clinical trial
3. chemistry, manufacturing and control of investigational drug

Question 7

what does an IND application contain

Answer 7

1. cover sheet
2. table of contents
3. part A- introductory statement and general investigational plan
4. Part B- protocols
5. part C- chemistry, manufacturing and control info
6. part D- pharmacology and toxicology info
7. part E- previous human experience with the investigational drug
8. part F- additional info

Question 8

what is involved in a Marketing authorisation application

Answer 8

1. common technical document (CTD)
2. new drug application

Question 9

what does the module 3- quality consist of in a marketing authorisation application

Answer 9

1. identity- recommended international non proprietary name
2. characterisation
   - structural info
   - chemical and physical properties
3. manufacturing process
4. control
5. stability

Question 10

what does the module 4- non clinical consist of in a marketing authorisation application

Answer 10

1. pharmacology
   - primary and secondary
   - safety pharmacology
   - pharmacological drug interactions
2. PK
3. toxicology
   - single or double dose
   - local tolerance
   - carcinogenicity

Question 11

what does the module 5 (clinical) section consist of in a marketing authorisation application

Answer 11

1. biopharmaceutical studies
   - bioavailability
   - bioequivelence
2. PK studies using human biomaterials
   - plasma protein binding studies
   - hepatic metabolism and drug interactions
3. human PK studies
   - tolerability study reports
4. human PD studies- healthy subject and pt PD
5. efficacy and safety reports
   - controlled clinical studies
   - meta analysis

Question 12

what does module 2 (summaries) consist of in a marketing authorisation application

Answer 12

1. non clinical and clinical overviews- critical discussions and assessments of results with conclusions
2. non clinical and clinical summaries should provide abbreviated factual data present as written summaries and support by summary tables