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■What is the ATMPs
I didn't clearly read from the EMA's description of the ATMP, whether the ATMP is as being a "sales approval" or a "preferential treatment that lowers the bar to obtain approval".

Perhaps the noun "ATMP" has three different meanings; I was confused because of the mix of these in the EMA's site.

Box1. Three different means of ATMPs

  • (1)ATMP as the name of the category, similar to 'drugs' or 'medical devices'
  • (2)Products that fall into the category of ATMPs can receive accelerated reviews compared to regular drugs. There appears to be a stage where the EMA confirms whether a particular product falls into this category or not.
  • (3) ATMP as a name for a form of sales authorization. ATMP in this sense can be sold within Europe.

If you said, "This product is an ATMP", it is unclear in which sense of (1) to (3) above.

  • In the sense of (1), it would be possible for any product to call itself an ATMP if it followed the "unapproved drug is a drug" sense.
  • The meaning of (2) is similar to what we mean by "RMAT designation" in the US. If it is an 'ATMP' in this sense, it can be understood as a "They can get a shortcut review."
  • If you want to clarify that the product have been given permission to sell, you should emphasize that you mean (3), for example, like "Approved for sale by the EMA as an ATMP".

■List for the ATMPs

I found unofficial list for RMATs by the private sector. According to this, the Full list of ATMPs around the date 20.05.2020 is as shown in Box 12, below. An ATMP here might be one that is an ATMP in the sense of Box 1, (3), or has been an ATMP in the sense of Box 1, (3), at least once in the past.

Box1. ATEMPBox2. Unofficial ATEMPs list as of 20.05.2020 from this site.

I couldn't find the official full list as far as I could find it. However, if you search for the name of the Box 12's product in the EMA’s database you will get a hit. Therefore, if the name of the product is known, it appears that it can be checked in the official EMA's database to see if it was at least once registered inapproved or at least once approved as the ATMP.

This statement strongly suggests that the "Approved as an ATMP" means ”Marketing approval has been granted across Europe”; although I didn't clearly read from the EMA's description of the ATMP as being a "sales approval" or a "preferential treatment that lowers the bar to obtain approval"Europe”.

Although, From the structure of thethis link strongly suggests that thisthere is marketinga marketing-authorisation way named "ATMP", as the link in the EMA's explanation contains the string "/marketing-authorisation/advanced-therapies/", perhaps the noun "ATMP" has three different meanings; I was confused because of the mix of these in the EMA's site.

  • (1)ATMP as the name of the category, similar to 'drugs' or 'medical devices'
  • (2)Products that fall into the category of ATMPs can receive accelerated reviews compared to regular drugs. There appears to be a stage where the EMA confirms whether a particular product falls into this category or not.
  • (3) ATMP as a name for a form of sales authorization. ATMP in this sense can be sold within Europe.

If you said, "This product is an ATMP", it is unclear in which sense he means (1) to (3) above.

  • In the sense of (1), it would be possible for any product to call itself an ATMP if it followed the "unapproved drug is a drug" sense.
  • The meaning of (2) is similar to what we mean by "RMAT designation" in the US. If it is an 'ATMP' in this sense, it can be understood as a "promised shortcut review".
  • If you want to imply that the product have been given permission to sell, you should emphasize that you mean (3). For example, it should say "Approved for sale by the EMA as an ATMP".

I found unofficial list for RMATs by the private sector. According to this, the Full list of ATMPs around the date 20.05.2020 is as shown in Box 1, below.

Box1. ATEMP list as of 20.05.2020

I couldn't find the official full list as far as I could find it. However, if you search for the name of the Box 1 product in the EMA’s database you will get a hit. Therefore, if the name of the product is known, it appears that it can be checked in the official EMA's database to see if it was at least once registered in the ATMP.

This statement strongly suggests that the "Approved as an ATMP" means ”Marketing approval has been granted across Europe”; although I didn't clearly read from the EMA's description of the ATMP as being a "sales approval" or a "preferential treatment that lowers the bar to obtain approval".

Although, the structure of the link strongly suggests that this is marketing-authorisation, as the link in the EMA's explanation contains the string "/marketing-authorisation/advanced-therapies/", perhaps the noun "ATMP" has three different meanings; I was confused because of the mix of these in the EMA's site.

  • (1)ATMP as the name of the category, similar to 'drugs' or 'medical devices'
  • (2)Products that fall into the category of ATMPs can receive accelerated reviews compared to regular drugs. There appears to be a stage where the EMA confirms whether a particular product falls into this category or not.
  • (3) ATMP as a name for a form of sales authorization. ATMP in this sense can be sold within Europe.

If you said, "This product is an ATMP", it is unclear in which sense he means (1) to (3) above.

  • In the sense of (1), it would be possible for any product to call itself an ATMP if it followed the "unapproved drug is a drug" sense.
  • The meaning of (2) is similar to what we mean by "RMAT designation" in the US. If it is an 'ATMP' in this sense, it can be understood as a "promised shortcut review".
  • If you want to imply that the product have been given permission to sell, you should emphasize that you mean (3). For example, it should say "Approved for sale by the EMA as an ATMP".

■What is the ATMPs
I didn't clearly read from the EMA's description of the ATMP, whether the ATMP is as being a "sales approval" or a "preferential treatment that lowers the bar to obtain approval".

Perhaps the noun "ATMP" has three different meanings; I was confused because of the mix of these in the EMA's site.

Box1. Three different means of ATMPs

  • (1)ATMP as the name of the category, similar to 'drugs' or 'medical devices'
  • (2)Products that fall into the category of ATMPs can receive accelerated reviews compared to regular drugs. There appears to be a stage where the EMA confirms whether a particular product falls into this category or not.
  • (3) ATMP as a name for a form of sales authorization. ATMP in this sense can be sold within Europe.

If you said, "This product is an ATMP", it is unclear in which sense of (1) to (3) above.

  • In the sense of (1), it would be possible for any product to call itself an ATMP if it followed the "unapproved drug is a drug" sense.
  • The meaning of (2) is similar to what we mean by "RMAT designation" in the US. If it is an 'ATMP' in this sense, it can be understood as a "They can get a shortcut review."
  • If you want to clarify that the product have been given permission to sell, you should emphasize that you mean (3), for example, like "Approved for sale by the EMA as an ATMP".

■List for the ATMPs

I found unofficial list for RMATs by the private sector. According to this, the Full list of ATMPs around the date 20.05.2020 is as shown in Box 2, below. An ATMP here might be one that is an ATMP in the sense of Box 1, (3), or has been an ATMP in the sense of Box 1, (3), at least once in the past.

Box2. Unofficial ATEMPs list as of 20.05.2020 from this site.

I couldn't find the official full list as far as I could find it. However, if you search for the name of the Box 2's product in the EMA’s database you will get a hit. Therefore, if the name of the product is known, it appears that it can be checked in the official EMA's database to see if it was approved or at least once approved as the ATMP.

This statement strongly suggests that the "Approved as an ATMP" means ”Marketing approval has been granted across Europe”. From the structure of this link strongly suggests that there is a marketing-authorisation way named "ATMP", as the link in the EMA's explanation contains the string "/marketing-authorisation/advanced-therapies/".

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MACI's EPAR has the following description(※).

This statement strongly suggests that the ATMP is a Europe-wide marketing authorization;"Approved as an ATMP" means ”Marketing approval has been granted across Europe”; although I didn't clearly read from the EMA's description of the ATMP as being a "sales approval" or a "preferential treatment that lowers the bar to obtain approval". 

Although, the structure of the linklink strongly suggests that this is marketing-authorisation, as the link in the EMA's explanation contains the string "/marketing-authorisation/advanced-therapies/", perhaps the noun "ATMP" has three different meanings; I was confused because of the mix of these in the EMA's site.

  • (1)ATMP as the name of the category, similar to 'drugs' or 'medical devices'
  • (2)Products that fall into the category of ATMPs can receive accelerated reviews compared to regular drugs. There appears to be a stage where the EMA confirms whether a particular product falls into this category or not.
  • (3) ATMP as a name for a form of sales authorization. ATMP in this sense can be sold within Europe.

If you said, "This product is an ATMP", it is unclear in which sense he means (1) to (3) above.

  • In the sense of (1), it would be possible for any product to call itself an ATMP if it followed the "unapproved drug is a drug" sense.
  • The meaning of (2) is similar to what we mean by "RMAT designation" in the US. If it is an 'ATMP' in this sense, it can be understood as a "promised shortcut review".
  • If you want to imply that the product have been given permission to sell, you should emphasize that you mean (3). For example, it should say "Approved for sale by the EMA as an ATMP".

For※.For reference, MACI appears to still have approved status at the FDA as of November 15, 2020. In other words, it's commercially available in the United States as of November 15, 2020.

MACI's EPAR has the following description.

This statement strongly suggests that the ATMP is a Europe-wide marketing authorization; although I didn't clearly read from the EMA's description of the ATMP as being a "sales approval" or a "preferential treatment that lowers the bar to obtain approval". Although, the structure of the link strongly suggests that this is marketing-authorisation, as the link in the EMA's explanation contains the string "/marketing-authorisation/advanced-therapies/".

For reference, MACI appears to still have approved status at the FDA as of November 15, 2020. In other words, it's commercially available in the United States as of November 15, 2020.

MACI's EPAR has the following description(※).

This statement strongly suggests that the "Approved as an ATMP" means ”Marketing approval has been granted across Europe”; although I didn't clearly read from the EMA's description of the ATMP as being a "sales approval" or a "preferential treatment that lowers the bar to obtain approval". 

Although, the structure of the link strongly suggests that this is marketing-authorisation, as the link in the EMA's explanation contains the string "/marketing-authorisation/advanced-therapies/", perhaps the noun "ATMP" has three different meanings; I was confused because of the mix of these in the EMA's site.

  • (1)ATMP as the name of the category, similar to 'drugs' or 'medical devices'
  • (2)Products that fall into the category of ATMPs can receive accelerated reviews compared to regular drugs. There appears to be a stage where the EMA confirms whether a particular product falls into this category or not.
  • (3) ATMP as a name for a form of sales authorization. ATMP in this sense can be sold within Europe.

If you said, "This product is an ATMP", it is unclear in which sense he means (1) to (3) above.

  • In the sense of (1), it would be possible for any product to call itself an ATMP if it followed the "unapproved drug is a drug" sense.
  • The meaning of (2) is similar to what we mean by "RMAT designation" in the US. If it is an 'ATMP' in this sense, it can be understood as a "promised shortcut review".
  • If you want to imply that the product have been given permission to sell, you should emphasize that you mean (3). For example, it should say "Approved for sale by the EMA as an ATMP".

※.For reference, MACI appears to still have approved status at the FDA as of November 15, 2020. In other words, it's commercially available in the United States as of November 15, 2020.

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It's interesting that, even though the MACI was Withdrawn as an ATMP in 2014, it was later approved by the FDA as the "first tissue engineering product" in 2016. However, it doesn't seem to negate the effectiveness of MACI from this document;Probably due to the applicant's market strategy, they did not renew.

It's interesting that, even though the MACI was Withdrawn as an ATMP in 2014, it was later approved by the FDA as the "first tissue engineering product" in 2016.

It's interesting that, even though the MACI was Withdrawn as an ATMP in 2014, it was later approved by the FDA as the "first tissue engineering product" in 2016. However, it doesn't seem to negate the effectiveness of MACI from this document;Probably due to the applicant's market strategy, they did not renew.

MACI
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