IDA consultats has been approached to provide a couple of slides that outline a regulatory roadmap, I thought I woudl share them with my readers as well, along with the notes that I provided to the speaker, I hope you find them helpful.

The pathway through MHRA/EMEA drug approval process

Speaker notes for slides

The first step is to put together your development plan, in the first instance you will require clinical trials outlines nonclinical outlines nonclinical safety outlines and GMP manufacturing plans. It is advised that you seek scientific advice at this stage unless your program is very much a vanilla program. This process of gaining a regulatory rubberstamp can prove very valuable in terms of de-risking your project and make you more attractive to investors.

In order to get your clinical trial program approved there are two routes that you can take:

There is a central review process that is run by a subcommittee of the EMEA, where you can submit your development plan and clinical trials protocols for central review this is not an approval process, it enables European wide feedback and comments upon your plans. It is voluntary for most programs however it is mandatory for biotech products and high-tech products for multinational phase 3 programs . You still need to apply for local approval after this and local ethics approval however it gives you an opportunity to countries that have a positive opinion about your program.

Most companies chose to go down the national procedure route, in which you have your clinical trial approved by the appropriate authorities in the UK this is the MHRA, you will then require local ethics approval, we advise you apply for both your CTA and your local ethics simultaneously in order to save time.

If your product is a high risk product such as monoclonal or similar, you will require an extra stage of approval by the EAG this will come before your standard CTA approval program.

You can then initiate your clinical trials programme.

For the scientific meetings and advice you will need a regulatory briefing book, this should be ideally no more than 20 to 50 pages 20 pages of the new programs 50 pages the programs are gone through a number of clinical trials, this should be very brief and to the point.

To start your official CTA process you will require full protocols, full case report forms, and a much more detailed briefing book.

In order to undertake your clinical trial you will require a CRO to manage it, it is recommended that you undergo a CRO selection process at a very early stage, you will require insurance, again the cost of insurance can be much reduced if you speak to your insurance company at a very early stage. You will require ongoing Pharmacovigilance cover, in most of the world pre-clinical and clinical trials programmes will require GMP clinical trial stock however there are a number of countries were full GMP is not required and “in the spirit of GMP” may be acceptable. This includes the USA Belgium and Holland.

I would recommend that you seek regulatory scientific advice between each of your clinical trials in order to establish that the results seen have not impacted on the regulatory acceptance of the overall design. This is probably not required if your results are exactly as you have predicted they would be.

Second slide

Once you have completed your development programme will require a product licence to sell your product in Europe. There are many routes for this: there is a central process run by the EMEA, a national process, the national process followed by mutual recognition, and decentralised process for products that are already on the market in the country.

There are many factors that go into the choice of routes to many to be discussed here. Whichever route you decide upon it is well advised to seek meetings with the regulators well before submission of your application in order to confirm acceptance of your planned route.

With the central process your application is made to the EMEA who then have it reviewed by two representative national bodies, if this is acceptable then Central European approval is granted and your product can be sold anywhere within the union.

In the national process you gain national approval with the body of your choice then you can sell your product in that country. At this point you can start a mutual recognition process where you use your existing approval to springboard approval into other selected states.

The decentralised procedure is the products are being on the market and have a market history in one or more European states, you can then proceed to gain regulatory approval in national states based upon that national approval.

Whichever route you take your require a common technical document or a an eCTD as they are known, this will ensure that your documentation is in a state that is acceptable in all this national states and also in the USA.

If you would like more detail in this area please get in touch with Damien Bové damien.bove@idaconsultants.com

Damien Bové works as a drug development consultant (pharmaceutical or biotechnology) and regulatory consultant, we work with our clients to define a drug  development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

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