Lecture 5 Donderdag
Market Authorisation Application
Steps in MAA
1. Preparation
2. Submission
3. Review by authorities
4. (inspections) -> for cause inspections
5. Q&A
Disadv. Of inspections; at step four they are very late, you have to go back in time + no time
to adjust data set. Therefor a lot of inspections have moved forward
MAA
-Results in licence to market an IP in a particular country or region
-Defines quality, permitted uses and restrictions
-Restricts promotional claims
-Defines packaging and labelling
Trials has to be executed by
-Protocol
-Ethics
-Credible data
-ICH-GCP
-Law 2001 & 2005 Directives + WMO
after step 5 Q&A, results in a licence to market, you have to make sure it is immediately
available in that country
MAA in EU
-Mutual recognition
-Centralised
-National filings only available for local products or some line extensions
Code of Federal Regulations (CFR) FDA
FDA- tasks
-New product review
-Post-marketing surveillance
-Setting standsards and writing regulations
-Manufacturing
-distribution
-Labelling
-Providing safety and efficacy
-Scientific research
-Regulatory enforcement and corrective action
1
, You can end up on the black list -> you are not allowed to do research anymore. It is only in
the USA, but it is publicly available. Something we, EU, can learn from.
FDA – CFR
Data from outside USA are not required by CFR in order to obtain approval.
Adv of international trials are:
-Higher number of potential subjects
-Marketing advantage
IND = Investigational New Drug
-Normal procedure
-Fast track
NDA = New Drug Application
-Normal procedure
-Abbreviation New Drug Application (ANDA)
Figure 1 Drug discovery
FDA- IND Application
Contains:
-Pre-clinical results
-All known information about the compound
-Clinical results
-Description of clinical development plan
-Investigator’s Brochure
-Qualifications of participating investigators
2
Market Authorisation Application
Steps in MAA
1. Preparation
2. Submission
3. Review by authorities
4. (inspections) -> for cause inspections
5. Q&A
Disadv. Of inspections; at step four they are very late, you have to go back in time + no time
to adjust data set. Therefor a lot of inspections have moved forward
MAA
-Results in licence to market an IP in a particular country or region
-Defines quality, permitted uses and restrictions
-Restricts promotional claims
-Defines packaging and labelling
Trials has to be executed by
-Protocol
-Ethics
-Credible data
-ICH-GCP
-Law 2001 & 2005 Directives + WMO
after step 5 Q&A, results in a licence to market, you have to make sure it is immediately
available in that country
MAA in EU
-Mutual recognition
-Centralised
-National filings only available for local products or some line extensions
Code of Federal Regulations (CFR) FDA
FDA- tasks
-New product review
-Post-marketing surveillance
-Setting standsards and writing regulations
-Manufacturing
-distribution
-Labelling
-Providing safety and efficacy
-Scientific research
-Regulatory enforcement and corrective action
1
, You can end up on the black list -> you are not allowed to do research anymore. It is only in
the USA, but it is publicly available. Something we, EU, can learn from.
FDA – CFR
Data from outside USA are not required by CFR in order to obtain approval.
Adv of international trials are:
-Higher number of potential subjects
-Marketing advantage
IND = Investigational New Drug
-Normal procedure
-Fast track
NDA = New Drug Application
-Normal procedure
-Abbreviation New Drug Application (ANDA)
Figure 1 Drug discovery
FDA- IND Application
Contains:
-Pre-clinical results
-All known information about the compound
-Clinical results
-Description of clinical development plan
-Investigator’s Brochure
-Qualifications of participating investigators
2
