Regulatory Submission and Approval Strategy
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Effective planning is the key to success
- Is your product a new chemical entity?
- Is your product authorised anywhere else?
- Are there any specific regulatory requirements for the class of product?
- What supporting data is available?
- What supporting data do you need?
- Are there any safety issues associated with your product?
Answers to these questions, and others, will determine the legal basis of your submission and the best assessment procedure for your application.
What is the procedure for MAA approval?
There are currently four available procedures in the EU:
- National Procedure
- Mutual Recognition Procedure (MRP)
- Decentralised Procedure (DP)
- Centralised Procedure (CP)
| National | Mutual Recognition | Decentralised | Centralised | |
|---|---|---|---|---|
| When is it used? | May be used if the product is not authorised in any MS | Must be used if the product is already authorised in a MS. May be used for new products | May be used if the product is not authorised in any MS | Mandatory for biotech, cancer, HIV, diabetes, neuro-degenerative disorders & orphan drugs |
| Who issues the Authorisation? | Issued by the MS. The product is authorised in one MS only. | Issued by the MS. The product is authorised in one MS only until MRP complete. | Issued by the MS. The authorisation is granted at the same time for all MS. | Single MA issued centrally and valid in all MS of the EU. |
| Opportunity for additional Member States? | MRP using the original MS as RMS | Repeat MRP second wave | Second wave MRP | Not applicable |
| How long does it take? | Officially 210 days. In practice can be much longer | Officially 420 days | If consensus is reached may stop at Day 105, 120, 150 or 210. Possible clock stop of 90 days. | Officially 210 days. |
- MS
- Member State
- RMS
- Reference Member State
- CMS
- Concerned Member State
How do I choose which procedure to use for my product?
Choosing the preferred procedure for your product can be a complex decision. You will need to consider where your product is in the development life cycle and your current and future marketing plans. Simply looking at cost and time to approval may not be the only considerations. For example, the Competent Authorities may not be able to comply with the 210 day timeline for National Procedures. Choice of RMS is crucial in the MRP as you depend on their assessment report, which they may be unable to produce as soon as you would like. Choice of RMS is also critical in the DP, as all Competent Authorities report a heavy workload and popular RMSs are oversubscribed, necessitating a 'waiting list' or early negotiation of a procedure start date. With the CP, providing acceptable translations of the agreed labelling into 23 official EU languages can be an onerous task.
Careful planning and organisation is needed to ensure that your application goes smoothly.
How can Akos help you?
Contact Akos. An experienced regulatory professional will be able to advise on the best strategy for your product. We can also help you to prepare applications, with subsequent follow through from submission to approval.
To discuss your regulatory questions with Akos please contact us:
Tel: +44 (0)1582 766 339
Email: regulatory@akos.co.uk