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Posted On: 09/09/2020 2:12:16 PM
Post# of 148984
Promising Innovative Medicine (PIM) Designation
My guess based solely on internet sleuthing is that this is what we are going for with the UK. Given that Remdesivir went through the UK's Early Access to Medicines Scheme (EAMS)
From: http://www.pmlive.com/pharma_news/uk_clears_n...ts_1340982
If you go to the EAMS Application page you will find information on Promising Innovative Medicine (PIM) designation
Then I dug into the guidance for applying for a PIM designation doc ( PIM Process ) which contains a flowchart for the process.
If I had to guess we are in the application stage for the designation
After the meeting...
Now, take all of this with a grain of salt because this doc is from 2014 and does not take into account COVID. If this is indeed the process being followed, the 4 weeks for a PIM meeting was shortened to 1 week. The decision could be made at the end of the meeting for all I know.
Interesting to note that the application actually has a section for "Pharmaceutical development" as well as "non-clinical and clinical data" which is exactly what was alluded to by NP in the CC.
Next step would be the "Scientific Opinion" ( Scientific Opinion Doc )
What is interesting is that this step of the process has 4 criteria
This seems to be where the real details of manufacturing are actually discussed. So perhaps they are getting a sense of manufacturing now to inform this process (I know this has been put forth by other members on this board)
In case you were curious here are the statistics on PIM designation (Step 1
and on Scientific Opinions (Step 2)
This to me suggests that it's a process that when taken has a high likelihood of success (perhaps because it is only suggested by the MHRA when they believe it should be pursued).
This has been what I am basing my analysis on currently but if someone has a different path you think they have taken please do share. Hope that helps Alyosha!
My guess based solely on internet sleuthing is that this is what we are going for with the UK. Given that Remdesivir went through the UK's Early Access to Medicines Scheme (EAMS)
From: http://www.pmlive.com/pharma_news/uk_clears_n...ts_1340982
Quote:
The Medicines and Healthcare products Regulatory Agency (MHRA) approved the drug under the Early Access to Medicines Scheme (EAMS), used to hasten access to unlicensed drugs for life-threatening or seriously debilitating conditions.
If you go to the EAMS Application page you will find information on Promising Innovative Medicine (PIM) designation
Quote:
The PIM designation will give an indication that a product may be eligible for the EAMS based on early clinical data. The PIM designation will be issued after an MHRA scientific meeting and could be given several years before the product is licensed.
Then I dug into the guidance for applying for a PIM designation doc ( PIM Process ) which contains a flowchart for the process.
If I had to guess we are in the application stage for the designation
Quote:
What happens next?
Your submitted designation application will be reviewed by the assessment team and an agreed designation meeting date will be set (normally within 4 weeks of the receipt of your request). The focus of the designation meeting is restricted to the potential of the medicinal product to fulfil the three criteria and is expected to last for up to one hour. The meeting will normally be face to face at the MHRA’s offices in London, although teleconference facilities can be arranged if this is the Applicant’s preferred option. Separate scientific advice meetings can be requested from the MHRA at any stage in the development of the product for other aspects (quality, non-clinical, statistical, pharmacokinetic, efficacy and safety, pharmacovigilance).
After the meeting...
Quote:
Following the designation meeting, the assessment team will make a recommendation to the internal scientific consistency review group, which will advise the Director of Licensing on whether to grant a designation or not
Now, take all of this with a grain of salt because this doc is from 2014 and does not take into account COVID. If this is indeed the process being followed, the 4 weeks for a PIM meeting was shortened to 1 week. The decision could be made at the end of the meeting for all I know.
Interesting to note that the application actually has a section for "Pharmaceutical development" as well as "non-clinical and clinical data" which is exactly what was alluded to by NP in the CC.
Next step would be the "Scientific Opinion" ( Scientific Opinion Doc )
What is interesting is that this step of the process has 4 criteria
Quote:
Criteria Criteria of an EAMS application
1 (a) Life threatening or seriously debilitating condition and (b) High unmet need, i.e. there is no methods available or existing methods have serious limitations
2 The medicinal product is likely to offer significant advantage over methods
currently used in the UK
3 The potential adverse effects of the medicinal product are considered to be outweighed by the benefits, allowing for the reasonable expectation of a
positive benefit/risk balance
4 The Applicant is able to supply the product and to manufacture it to a
consistent quality standard (GMP)
This seems to be where the real details of manufacturing are actually discussed. So perhaps they are getting a sense of manufacturing now to inform this process (I know this has been put forth by other members on this board)
In case you were curious here are the statistics on PIM designation (Step 1
Quote:
EAMS step I PIM designations - April 2014 to August 2020
Applications received 116
PIM designations granted 88
PIM designations refused 18
PIM designations withdrawn 4
PIM designations pending 6
and on Scientific Opinions (Step 2)
Quote:
EAMS step II applications - April 2014 to August 2020
Applications received 44
Opinions awarded 32
Opinions refused 3
Opinions Withdrawn 5
Opinions pending 4
This to me suggests that it's a process that when taken has a high likelihood of success (perhaps because it is only suggested by the MHRA when they believe it should be pursued).
This has been what I am basing my analysis on currently but if someone has a different path you think they have taken please do share. Hope that helps Alyosha!
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