regulatory authority/approvals

Question 1

Outline the main responsibilities of the Drug Regulatory Authorities globally. What are the main functions of drug regulatory authorities? 7

Answer 1

1) Ensure all medicines establishments are licensed, such as manufacturing, importation, distribution.
2) Activities/premises comply with GMP and GDP
3) Assess monitor QSE of medicine before marketed and on the market to prevent harmful medicines from reaching the public.
4) Regularly inspect and control informal market to prevent illegal trade of medicine
5) Monitor advertising/promotion of medicines to inform public and professionals.
6) Participate in regulatory networks to exchange information and promote collaboration.
7) Identify any weakness from performance and take corrective action in regards to compliance with regulatory requirements.

Question 2

Outline the main responsibilities of the Drug Regulatory Authorities globally. What are the main functions of drug regulatory authorities? 7

Answer 2

1) Ensure all medicines establishments are licensed, such as manufacturing, importation, distribution.
2) Activities/premises comply with GMP and GDP
3) Assess monitor QSE of medicine before marketed and on the market to prevent harmful medicines from reaching the public.
4) Regularly inspect and control informal market to prevent illegal trade of medicine
5) Monitor advertising/promotion of medicines to inform public and professionals.
6) Participate in regulatory networks to exchange information and promote collaboration.
7) Identify any weakness from performance and take corrective action in regards to compliance with regulatory requirements.

Question 3

What is the Centralised procedure for drug approvals in the EU? used for and how does it work? What products is it mandatory for?

Answer 3

• Pharma company submit single marketing authorisation application to EMA. European Medicine Agency.
• The EMA issue recommendation to the European commission after review.
• Commission grants a centralised marketing authorisation in all EU member states and EEA (European Economic Area) countries. (grant within 67).
  Used for/mandatory products:
• Human medicine containing a new active substance to treat certain disease such as autoimmune, cancers, diabetes, neurodegenerative, viral diseases.
• Medicine derived from biotechnology processes.
• Medicine for rare diseases
• Veterinary medicines for use as growth / yield enhancers.

Question 4

Explain how the mutual recognition drug approval process works in the EU.

Answer 4

• The marketing authorisation granted in one member state and is able to be recognised in other EU countries.
  Product has already been approved In at least one member state.
• This member state us known as reference member state (RMS).
• RMS submit evaluation to other member states (concerned member states -CMS).
• CMS asked to accept decision of RMS
• Procedures in place for any disputes.

Question 5

What is the EU decentralised procedure for Drug approvals?

Answer 5

• Medicine not authorised in the EU, but can be simultaneously authorised in several EU member states.
  Procedure:
• One member state acts as an RMS to conduct evaluation and issue assessment report.
• Other member state accepts the decision or ask questions/ for more information.
• When resolved/ accepted the other member states will issue marketing authorisation for product.

Question 6

What 2 licences are required for manufacturing and selling a pharmaceutical product? and how do they obtain these?

Answer 6

1) Manufacturing licence
Awarded on the basis of a GMP inspection by a regulatory authority (national competent authority)
2) Marketing authorisation
Awarded based on a submission of a dossier document summarising the quality, safety an efficacy of the drug product. format of the common technical document (CTD).

Question 7

What is the Common Technical Document (CTD)?

Answer 7

• An intentionally agreed format to prepare an application dossier for registration of medicine that is intended to be submitted to regulatory authority.
• The dossier document summarises the quality, safety and efficacy of the drug product.
• Used in across Europe, Japan, USA.
  Module 1 – administrative and prescribing information (not part of CTD)
  Module 2 – overview and summary of modules 3 to 5
  Module 3 - quality data
  Module 4 – preclinical/ safety data (animal testing)
  Module 5 – Clinical trials (human testing/efficacy data)

Question 8

why is it important? CTD

Answer 8

• Global Harmonization of application format allowing electronic submission easy to handle, more secured, updates in data easier to track
• Easy to understand, predictable format Save time and resources to compile dossier and review.
• Eliminates need to reformat information for submission to different ICH regulatory authority
• Good review practices – reviewing of each application more easy avoid omission of critical data or analyses which can prevent unnecessary delays in approval.
• Exchange of regulatory information between regulatory authority made easier