Ensuring Digital Signature Lawfulness for Pharmaceutical in European Union

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

[Music] hi everyone welcome back to my channel i'm neha parasha working in a healthcare company and based in germany in today's video we'll talk about the marketing authorization pathways in e there are four types of marketing authorization pathways in eu centralized decentralized mutual recognition process and national so let's see each of these pathways one by one but before that let me ask you one question how do you decide which pathway will you choose for your drug if you don't know the answer then don't worry for sure by end of this video you will get the answer to all those questions let's start with the first pathway which is called centralized as the name indicates centralized meaning getting the drug approval central your drug is approved by one central body and this approval is valid for all the european economic area in short this european economic area is called as eea which include not only 27 eu countries but also three additional countries which are iceland list einstein and norway so the european economic area or eea is comprised of 27 eu countries and these three additional countries now what is the central body or community who gives approval there is a body called chmp which gives opinion and based on this opinion indian ec gives the final approval so eema's committee for medicinal product for human news which is in short called as chnp or committee for medicinal products for veterinary use which is called as the cvmp so one is for human medicines and one is for the veterinary medicines so this chmp or cvmp these committee they carry out a scientific assessment of application and gives the recommendation or opinion and based on this recommendation or opinion in the end european commission or which is called as easy gives a final approval in the end so this easy decision is issued within 67 calendar days uh after receiving the ima's opinion if you are not clear how ema chm p c v m p and e c they all are different then let me know in the comment section i'll make a separate video on that so now let's see when to submit the centralized application the centralized procedure is compulsory for some category of product meaning if you are dealing with any such kind of products then you have to compulsively file a centralized pathway and what are those products let's see that product containing a new active substance which are used to treat what kind of diseases let's see that hiv or aids cancer diabetes neurodegenerative diseases autoimmune and other immune dysfunctions viral diseases biological medicines which are derived from biotechnology process such as genetic engineering advanced therapy medicines such as gene therapy somatic cell therapy or tc engineered medicines orphan medicines which are used to treat real diseases and the veterinary medicines which are used as a growth of yield enhancer so these are the products for which the centralized pathway is mandatory but do you know why is it so why is it mandatory to go buy a centralized pathway for such kind of products because they want to ensure that all the eu area gets privileged for some kind of critical or innovative medicines and not the only few countries therefore you need to submit by a centralized pathway for such kind of products so all the eu country gets benefit out of it however there are some products for which the centralized pathway is optional what are those let's see that for example product containing new active substance for indications other than those which we just discussed now right which we discussed so far apart from any other indication if you are having any new chemical entity we can it's an option whether we can go by a centralized or not so this is optional second for therapeutically innovative products for such kind of products also is optional and drugs with the clear added value for community and authorization will be in the interest of public for such kind of products also the centralized pathway is optional now the question comes what is the approval timeline and you can see this figure shows you the high level timelines on the centralized procedure and approval centralized procedure have some benefits what are those benefits let's see that as well it has well-defined timelines you will receive questions at particular day so you know you will receive question a day 120 or day 180 after the application which make applicants life much easier from a planning point of view there are multiple options for scientific advices before centralized procedures so applicant can make use of this and applicant can seek the chmp's advice in advance before the submission because the one submission is done for entire eu countries and one review is performed all together therefore it's easier to handle in terms of dozier preparations and submissions also we receive single approval in all member states right which also makes it easier to manage from post approval on lifecycle point of view and only one submission is required to be performed for product information for example smpc labeling package leaflets of course the submission has to be done in all eu language so these were some kind of benefits which you will get if you are going by a centralized pathway but we need to check what are the disadvantages also right so if we are going by our centralized pathway we need to check with health authority we are eligible for centralized pathway or not and this need to be done before 7 to 18 months before submission we have to submit a request which is called as a letter of intent before doing our submission so we have a proper process for it then what other disadvantages are there applicant cannot select the reporter or co-capital so that's also a disadvantage um copies of all the product information are required in all the eu language so this is a heavy work right from a preparation point of view so this is also one of the disadvantage and the last disadvantage is either you receive approval in all the member state or in none of the country so as we discussed what are the advantage and what are the disadvantages of the centralized pathway as we just saw when we need to submit the centralized application and how this work centralized pathway are used when we want to get the centralized approval of drug for all the eu countries but if we want uh any product to be registered in more than one member state which do not qualify for the centralized procedure the applicant must use either the decentralized pathway or the mutual recognition pathway which we are going to discuss going forward so there is a clear difference when to use mrp when to use dcp we'll see that one by one so now first let's start with the mrp mrp is used if we aim to register the product in more than one member state and the product has already received a marketing authorization in any one member state at the time of application we can use this pathway only when there is already a national marketing authorization in at least one member state for that product right now you want to add additional countries then you can use this pathway called mrp which is mutual recognition pathway and the name is self-explanatory this concept is based on idea that all the eu countries have a mutual recognition between each other they have sufficiently harmonized standard which they use for the assessment of your application so if a license approved in one member state it should be mutually recognized in other member state and that's the idea behind mrp the country where the product is already approved is called reference members trade in short it's referred as rms the additional member states which are added are called concerned member state which is called as a cms in short so there are two steps for mrp processor first step is national phase first we need to receive national approval in any one country which will be called as rms and the second is mrp phase where we add the additional countries and authorization is granted in those additional countries there can be the cases when rms and cms have conflict with each other and they do not agree on the same ground for approval in such cases cmdh which is a group which is a coordination group for mutual recognition and decentralized procedure this is the full form of cmdh okay so the name is self-explanatory this group is made to coordinate between rms and cms for both mrp processes and for decentralized procedure so this group cmds it supports to reach the agreement in case there are any disagreement between rms and cm so this was all about mrp there is a third pathway which is called decentralized pathway let's see what it is many people are confused what is the difference between mrp and decentralized they have reached out to me asking for this clarification so we can see that now in this video let's see that so decentralized procedure in general follows the same principles of mrp both are applicable if you do not want to register the product in entire eu but you only want to register in few countries okay so you can go by decentralized procedure or by mrp any of these processors but when to go for which procedure that's what we are trying to understand here right so the ds dcp is to be used if we aim to obtain marketing authorization in several member state and if the product has not yet approved a marketing authorization in any member state so your drug product has not received marketing authorization even in a single country so far so what you can do you can go by dcp and you can register your product simultaneously in all of those countries for example if you want to register your product in only six countries then we can register our product in these six countries using mrp or using decentralized but when we can use mrp when you already have the approval in one country already then you can add additional countries during mrp but if you do not have approval in any of the countries then you can simultaneously submit your application to all these six countries using the bc so that's how we can proceed so the main difference between mrp and dcp lies in the fact that in dcp you can make submission all the six countries simultaneously while in case of mrp we need to wait for approval from rms before the new application or before the new country is added okay so dcp also has a concept of rms and cms exactly like mrp where out of these six countries one country will be selected as a rms other five countries will be cms we will be in direct contact with rms for the application review this rms will coordinate with other cms so there are two steps for dcp process as well the first step is assessment phase when all the countries review the application this period may last from 120 days or till 270 days depending on the queries if we receive the queries the period get extended and once the assessment phase is completed then all those six countries will give you the application at national level this is the second step all the relevant documents in local language are reviewed and this phase is called the national phase so in mrp also we had two phases or two steps and also in the then decentralized we have two steps but these two steps are different for both the procedures again sometimes rms and cms they can have some conflicts and they don't reach to an agreement on the same ground in this case they reach out to cmdh for the coordination decentralized procedure also has some benefits what are those benefits let's see that we can choose in which country we want to apply depending on the market demand so it's in our hand in which countries we want to go we can select those country and go by us decentralized procedure we can select rms but you remember in centralized procedure we do not have this option to select the repertoire on our own but for decentralized procedure you can select which country do you need or do you want as an rms we can withdraw country which are having major objections during the review process but only up to 120 days not after that so that's also an option provided in this enterprise procedure if early agreement reaches between cms and rms then this decentralized procedure is possibly the faster route compared to other registration pathways so we have to see all these benefits we have to consider all these benefits while making our regulatory strategies okay so these were the advantages of the decentralized pathway but this pathway also has some disadvantages or drawbacks what are those disadvantages or drawbacks let's see that one by one first availability of rms can be one of the issues as it takes one to two years to get a slot for some member states so that really gets difficult sometime if large number of cms are involved then this would become more complex to manage including the dossier preparation submission response to query during reviews and post approval and the life cycle management right more countries you have more difficult it becomes by a decentralized route right so if the settlement or agreement is required the settlement process can also take long time and if you have more countries then it's the same question again right even if the rms and cms gets agreement but some time national phase step can take much more time than expected and this delay the marketing of that truck so this are the so these are the advantages and disadvantages which we have to keep on in our mind while making the regulatory strategies right there is also four category called national pathway meaning if an applicant wishes to get a license in one member state an application must be made to that particular national health authority of that country which then issues a national license so this was all about centralized mrp decentralized and national i have summarized the details of each of these four types of pathway in this figure which include who approves them what are the timelines for approval and which country the authorization is valid in so you can just go through this figure if you want to summarize or brush up the concept now before we end this video do you know what is sunset clause if you know the answer then let me know in the comment section if not then don't worry we'll discuss that in some of the future upcoming videos the purpose of this video is to give you an overview on drug approval pathways i make a new separate series where i'll explain further even the minor details of these pathways what happens when the drug application is under review what happens after the review is completed what happens when the product is approved can we directly market the drug after approval or is there any process or steps which we need to consider even after approval lots of questions right this is interesting so all these aspects will be covered in the new series so let's stay tuned for next upcoming videos [Music] you