Unlocking eSignature Lawfulness for Pharmaceutical in European Union

How to eSign a document: eSignature lawfulness for Pharmaceutical in European Union

thank you hi everyone welcome back to my channel working in a Healthcare company and based in Germany in today's video we'll talk about the timelines and procedure for centralized pathway in EU in last video we saw that there are four types of marketing authorization Pathways in EU centralized decentralized which is called DCP Mutual recognition procedure which is called MRP and the fourth one is National we talked about the details and differences of each of these Pathways now we'll pick each one of these pathway and we'll talk about it one by one we'll see what are the regulations or directive applicable for this Pathways what are the regulatory bodies committees or organizations involved in it what are the steps involved in how to apply for it what are the timelines for review and approval let's start with centralized pathway in today's video let me ask you one question if I want to go buy a centralized procedure then which regulation should be followed do you know the answer the centralized procedure falls under this regulation so entire procedure is described in detail under this regulation now let me ask you second question what are the regulatory bodies committees or organizations involved in the centralized procedure do you know the answer as I mentioned in the last video there are two main bodies which are called chmp the full form is committee for medicinal product for human use as the name indicate this committee is for human drugs and the second is cvmp the committee for medicinal product for veterinary use which is for veterinary products so these are the two main scientific committees who give opinion where the project should be approved or not and based on their opinion European commission which is in short called EC it gives the final decision if our product is approved or not so this happens in a case of centralized procedure but but to know what this chmp is what are the members of the chmp and who all are part of it so the chmp is kind of a group of few people who are these few people let's see that as one chair person this chairperson is elected by the chmp members only right and one alternative to this person then one scientific expert member and one alternate to this member which is nominated by each member state from European economic area I hope you remember from last video what is this European economic area this is nothing but EU and three additional countries right so we have a representative or a scientific expert from each of these European economic areas country and they all are part of chmp then we have five co-opted members and these are not the fixed members of chmp okay whatever members we are talking about chmp right now uh they are not the fixed number meaning these members are not part of chmp throughout their life okay so these members and all these alternative members they are appointed in the committee for a period of three years on a contract basis so this contract will be renewable so after three years they can again serve for next three years and then again for next few years so that's how it works now let's talk about another organization which is involved in a centralized procedure what is that easy European commission right do you know what is this European commission I is also some kind of committee like chmp or this is something else let's see that so it's a governing political body uh this actually works as a Cabinet Government so it has 27 Commissioners uh one commissioner or one person from each EU countries so each of these commissioner they work for different different kind of policies and there is a precedent there is one president in this EC this President decide which commissioner will be involved in which kind of policies okay so chmp was a committee on the other hand easy is a political body or you can say like a Cabinet Government right so now you know what chmp is and what EC is now let's see what are the steps involved in centralized procedure how to go for it how to apply for it so as soon as you decide that you want to go buy a centralized procedure then you need to prove that your product is eligible for centralized procedure how to do that if a product is falling under mandatory scope of centralized procedure do you remember what is mandatory and what is optional scope of centralized procedure I discussed that in last video so you can refer that so basically if your product is falling under mandatory scope of centralized procedure it's fine you already know that you will go by a centralized procedure but if it is under optional scope so we would need to justify uh why we think that it is eligible for centralized procedure right uh but let me ask you how do you decide if your product is eligible for centralized procedure or not and how will you justify it let us do some homework here what what think about this molecule called ibuprofen this is used for pain and fever right now you tell me what do you think ibuprofen if this is used for pain and fever will it fall under centralized scope or not think for a minute and then answer if your answer is no then you are right but why because this is an old established product this is not any new active substance right and also this is not used for any life-threatening kind of diseases this is used just for a pain and a fever right those kind of conditions so this will not fall under centralized procedure but what if ibuprofen is to be used for Alzheimer's disease think about it then yes it will fall under centralized scope and why because you have done a significant therapeutic Innovation and the approval of this drug for Alzheimer's will be in the interest of public right so that's how the eligibility need to be evaluated for your products think about the second drug what do you think this diclofenic injection which is used as a painkiller does this fall under centralized scope or not think about it again the answer is no why because again this is an old established product this is not any new active substance and this is not used for any life-threatening condition or diseases that we discussed in last video right but what if the diclofenac is used by using some Innovative form of delivery system instead of normal injection then yes it can fall under centralized scope why because you have done a significant technical innovation in that case so which can make it eligible for the centralized procedure so once you've decided if your product is eligible for centralized procedure or not then you need to follow certain steps see what those steps are first you send the eligibility request to email this is done between like 18 to 7 months before the submission once you are done with sending your eligibility request to Ema then in the next step you will submit your letter of intent that you would like to submit marketing authorization application for your product by centralized procedure this has to be done before 7 months and once you are done with this then you are appointed with reporter and co-wrapater uh this happens around six months before the submission now you know you will be thinking what is this new term what is this reporter and core Capital so as we just learned that chmp committee has many members right out of these chmp members one member is appointed as reporter and one person is appointed as core Capital so the Appleton and core Appleton they are like the main person or leader of the class so what they do they are like spokesperson of chmp this person will first review and write the review assessment report and he will send this assessment report to all other chmp members for their comments so basically he is that one person who decide or leads entire review process okay uh this repeater or core aperture they are appointed normally based on their expertise like which therapeutic area um if it's anti-cancer of or it's antiviral so basically in which therapeutic area they are expert in So based on this if the drug of same therapeutic area comes for review then this person will be appointed as an Appleton right so this is how it's decided then one important thing which you should know about this uh EMA will not consider our proposal or preferences right so if we think that we can influence their decision that this person should be appointed as rapid and or core Capital they'll not listen to you so EMA will decide which one which person to be assigned for which particular product for review also just for you to know that for Advanced Therapy medicines that in short called like atmps for these kind of product rapidly is appointed from a committee called cat the committee for advanced therapy so like we have chmp similar to that we have committee for advanced therapies which deals with the product which are like Advanced therapies maybe in my future videos we'll talk about this as well also for review of rmp which is a risk management plan there is a separately rapid appointed from a separate committee called Prague the full form is pharmacovigilance discusses and we'll see that what all these committee do but just for now you should know that for rmp the rapper and co-opter are appointed from a prac which is a committee and for Advanced Therapy uh the reporter and co-operator is actually appointed from a cat which is a committee for advanced Therapies so basically if you join the chmp then you can also be one of the capital or core Day based on your expertise okay so now let's see what happens once repeater and co-repator are assigned in Next Step you submit your ma application a validation period of 14 days in which your application is reviewed that it is complete from an administrative point of view so basically this validation phase does not involve a detailed scientific review right the scientific review starts once this validation phase is completed after the review whatever comments reporter has he or she will prepare a draft assessment report in short I will just refer in my video Dar so this draft assessment report they will prepare by day 80 and they will send this draft assessment report to all the chmp member and also to us as an applicant so that we are already aware that what are the preliminary or draft questions or comment reporter has so reporter sent this to us as an applicant they also send it to the chmp members so in parallel all the chmp members they will make their review and if they have any additional questions or concerns or comment so they will add this in this preliminary report and can Consolidated final comments and questions will be sent to us as an applicant by day 120. also the comments from Prague on rmp that is risk management plan they are also sent to us in this Consolidated assessment report so day 80 is the timeline for draft question you need not to respond to health authority after day 80. only when you receive the Consolidated list at day 120 then you need to respond to health authority after day 120 the clock stops for first time so that you can prepare your response during this clock stop period you work hard to prepare the responses to these questions and during this response period the clock is stopped okay only once you send your response to health authority then only the clock will start okay usually this period is three to six months once your Center response to health authority the clock will start again and again the same cycle will follow meaning like day 80 now you have reached day 150 and day 20 now you have reached day 180 so at day 180 you will receive the second round of questions and again the clock stops you again prepare your responses this time frame usually uh generally lasts from one to three months once you've provided your response then the clock is started if required uh that still some open questions or comments are there or something is not resolved we can have an oral discussion with chmp if required they can also consult with external experts so they can take help of external experts right through a scientific Advisory Group or ad hoc expert group committees so at day 210 chmp makes a recommendation whether or not our product should be granted a marketing authorization okay and if yes under which condition of use the authorization is granted in between the submission of product information like smpc labeling and pil that happens and at day 277 that means 67 days after the chmp opinion European commission either grants or refuses the marketing authorization this is the end of the procedure to get the approval then it's a party time for us actually it's a party time for entire company right it's a big celebration for all of us so what happens once we get approval I think we should be aware about that also so 23 days after this approval that means at day 300 EMA published a set of documents on their website and this is called ipal European public assessment report if you want to know what a pair is how to look for this information in a bar then let me know in the comment section I'll make a separate video on this topic okay this was all when we got that approval let me ask you a question if chmp gave a negative opinion on your product is hard and fast rule that you have to accept it as such even if you think their opinion is not correct what do you think is no means no in that case that's not the case we as an applicant can request a re-examination of chmp's opinion we would need to justify on what basis or ground we want to challenge their opinion and make and appeal this a field need to be made within 15 days after we received the notification from the chmp in this case of appeal a different reporter and core Capital are appointed to us so they will re-examine it from a fresh different point of view during this re-examination they look only at the points which are raised by us in our appeal so we as an applicant cannot bring any new data or evidence at this stage because that will not be fair chmp gave to your opinion the negative opinion based on the initial data that we provided to them and when we made appeal we cannot come with any new data and say see we have this data now give us approval that cannot happen you cannot bring any new facts on the table which was not discussed before also we have this option that we can request the committee that they should take help or the consultation with a scientific Advisory Group if we are not agreeing to their opinion also it is important for us to know that if an expert group was already consulted during the initial evaluation this time different expert will be evaluating or will be doing the re-examination okay so this re-examination lasts up to 60 days at the end of re-examination chmp adopts a final opinion so the negative opinion can also turn positive opinion in such cases interesting isn't it yes so this was all about the centralized review procedure and timelines but before we end this video do you know what are the timelines for decentralized and MRP procedure if you know the answer then let me know in the comment section if not then don't worry we'll discuss about this in my next upcoming videos till then let's stay tuned foreign