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Is paradigm shift is close to us? – EMA’s public consultation on evaluation of anticancer medicinal products

European Medicines Agency (EMA) recently published an open consulation about the evaluation of anticancer medicinal products.

The concept paper anticipates that EMA considering to change the current assessment procedure from indication (location) based approval to the pathological mechanism approach.

For details please check the original document:

The partial implementation of this new approach had been already made in the US. In 2017, FDA approved pembrolizumab for the treatment of adult and pediatric patients with unresectable or metastatic solid tumors that have been identified as having a biomarker referred to as microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR).
For the first sight maybe it is not a big change but it has really deep impact on our current system.

By the time of approval of pembrolizumab, every other anticancer treatments were approved based on the origin of the cancer cells. That is why we call them skin, brain or lung cancer. Due to this approach clinical trials had to be conducted for brain or lung or skin cancer separately, even if the common biochemical and pathological routes were proven. As a consequence the Indication section has became enormous.

If EMA truly consider acceptable to implement new this assessment approach this will change and we all need to reevaulate our current practices within the full spectre of pharmaceutical industry.

Repurposing of currently owned drugs will work fine and the companies can win dozens of patents but this won’t work too long. Find new signaling pathways will be essential and in silico start-ups will be really valuable in the race.

Point-of-care testing (POCT) devices will produce huge amount of money. For every medicine a test will be needed to prove that the medicine fits into the indication. If the company can develop a good POTC and sell along with the medicine (as some company has already started) the share-holder will be really satisfied.

Medical experts and regulatory officers needs to be prepared as all new regulations as conseqence will keep them busy for a while.

Biochemistry studies will be strongly supported in order ot detect and prove all type of cancer signalling pathways. To make this possible the instrumental background should be improved fast. Currently only 20% of protein-protein interactions are revealed and the most popular high-throughput methods creates many false positive findings. Well designed and characterised in vitro cell line will be alse greatly appreaciated.

This is a great opportunity to the research groups to create some outstanding result and develop cooperation with industry.

Clinical trial settings planning and the trial inclusion and exlsusion criterias will be based on biomarker tests. Maybe less trials will be started but the laboratory background will be more important. The biostatistical model also needs to be tailored accordingly.

Do you have further idea how can this novel approach change pharma insutry? Please let me know in comment.

What kind of effect does automation have on your job as Regulatory or Pharmacovigilance professional?

What kind of effect does automation have on your job as Regulatory or Pharmacovigilance professional?

Nowadays you can hear about automation even in the grocery near to your home. Accountants, brokers, cashiers, taxi and truck drivers, lawyers can read articles about fast growing start-ups which are planning take their jobs via automation.

But somehow our field as regulatory and pharmacovigilance professional looks safer. We are communicating with local offices, external partners, and authorities on daily basis. We have complex process with decision points which can not made by computers, right?

Be honest to yourself and think about your daily tasks. How many documents are linked from one system to the other by you? Are you spending time for cover letter writing when you mainly copy/paste information from you internal system? How much of your working hours do you spend for tasks like this?

According to my experience 30% is the lowest rate. This could mean that 30% of the workers on our field can lose their job if companies could solve all issues around automation. Furthermore I know personally at least 2-3 solutions which could do the above listed tasks without changing your current IT system.

I don’t want to advertise any company here, so just google for Robotic Process Automation (RPA) and you will see many solutions.

For the first glance it can seems scary. Will you loose your job?

I have some insight to RPA solutions so I would say probably you won’t. You will need to change your approach, but you have every chance that you can keep it.

In my following articles I will give you deeper insight to RPA solutions and answer to the following questions:
1. What are the biggest challenges which need to be solved before a company can introduce RPA?
2. How will regulatory/pharmacovigilance RPA look when it will be introduced?
3. What will be your role in an RPA using company as regulatory/pharmacovigilance professional?

Marketing Authorization Transfer

Are you preparing for Marketing Authorization Transfer? You should check your process again for important little details

Marketing Authorization Transfer (MAT) can cause seriuos extra workload on every related departments. As a consequence sometimes there is not enough time to ensure tha cross-departmental communication flows efficiently and important details can be missed out. Most of the administrative work is done by the Legal and Regulatory Departments but clear communication among Pharmacovigilance and IT is also essential.

If you have only a few affected products, it is usually not a big deal to handle the process. However, when a bigger portfolio moves even experienced Regulatory professionals can forget about the importance of pre-defined rules between companies.

Just consider the following few points and you will see what is the issue:
• The approval process of bigger transfered portfolio can last longer than expected. Are you prepared for handling some products even long after the official deadline determined in the MAT contract?
• You need to be really lucky to transfer only products where no other assessment is ongoing. You need to agree with your MAT partner how to handle the transition in these cases.
• Companies track regulatory submissions really differently. Consult with you IT department and check the partner’s system. Maybe they don’t track the workflows or have different steps/deadlines which needs to be syncronized.
• Your compliance measurement points might track different actions compared to the partner. Who will be on charge when an issue pops up?
• You have 30 days reporting deadline for XEVMPD (EU countries) after MAT. Will you receive every necessary documents in time?

And these are just a few points on my list what I check while preparing for a MAT.

Sometimes it is worthy to consider the involvment a third party consultant in order to mediate the MAT. Providing access to the consultant for the Transferor’s and Transferee’s system can be really helpful as she/he will have a comprehensive overview on the overall tasks.

Now you should check your MAT process again and determine what kind of tasks are really essential to the successfull transfer.


Are you aware that new MedDRA version has been implemented recently? This will affect your regulatory submissions also.

Are you aware that new MedDRA version has been implemented recently? And how about your organization? I will point out a few pharmacovigilance and regulatory processes which are usually missed out during a MedDRA version update.

New MedDRA version is delievered twice a year to keep updated more than 100 000 terms covered by the Dictionary. In theory many of us know about this however it is rarely implemented fully in every day work.

First let’s take a closer look how MedDRA codes are updated:

The MSSO (MedDRA Maintenance and Support Services Organization) collects change requests from users during the whole year. They assess the eligibility of the requests and decides if it can be implemented in the upcoming version.

There are two MedDRA updates per year. In every March X.0 version release is distributed while in September X.1 release will be available. In the beginning of this September, version 21.1 was just released!

But be careful! A new release version of MedDRA should become the reporting version on the first Monday of the second month after it is released.

This means that you do not need to report and submit information under 21.1 version yet but this the right time to prepare for it.

Let’s see where MedDRA codes are used within a pharma company

MedDRA codes are used to ensure that pharma companies and authorities are on the same page during the whole lifecycle of a medicinal product. From clinical phase I is a long jurney to the withdrawal so I can ensure you that the documentation of the product will be updated many times by new MedDRA versions.

Keep in mind that Adverse Event Reports in clinical trials and in post-marketing, MAA, SmPC, CCDS, PIL, PSUR and RMP documentation should be always submitted under the current reporting MedDRA version!

Seems easy right? Well, not necessary..

Please think through your whole process:
•  Are case processors takes into account the possible changes?
• Are you sure that your Medical Department perform the update when implement the recent updates into the SmPC?
• What happens if a new version comes into effect just before you submit the variation/renewal package?
• During xEVMPD update are you ensure that you are reporting with the last version? And what about your internal database?

There are many point which can be missed out. Therefore when your next SOP update comes spend some time to identify where is MedDRA coding is used and implement a few simple rules about version handling. It will spare you a lot of time in the future.

You can read more about MedDRA coding and version update in the official training material following the link below.