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According to The Alliance for Regenerative Medicine, the following six Tissue-Engineered Products are available in Europe.

  • Spherox
  • Novocart 3D
  • ReNovaCell
  • ReGenerCel
  • Vergenix FG
  • Vergenix-STR

I searched these products using the EMA's database. As a result, for the Spherox, complete information was obtained from the database. However, products other than that, I could not find any evidence of approval except for newspaper articles, etc.

Probably, these are approved / approval as CE marks or ATMP. But, I cannot confirm whether it is registered in the CE mark or ATMP?

Originally my question is about the tissue engineering products not in the EMA's database but 'approved' in Europe. However, I'd like to focus to ATMP.

【My Question】

  • How can I confirm that these five products have really received the CE mark or acceptance as ATMP?
  • The FDA's RMAT designation appear to be a ticket to get the preferential treatment on a review preference, but not to be approved. What happens when a candidate drug becomes an ATMP? Can the products approved as an ATMP be marketed in Europe?

I want publicly authorized information; It does not include such as newspaper information or the manufacturer's website.

For ReNovaCel, ReGenerCel, and Vergenix, the manufacturer, Avita says;
”Avita launched ReGenerCell and ReNovaCell in Europe. Both autologous cell harvesting devices have CE Mark approval.”

However, no information seems to be registered. Additionally, ReNovaCel and ReGenerCel are alleged to have FDA approval, but we can not find any files on the FDA database. (However, ReCel of the company was registered in the FDA DB)

There were news articles about the Vergenix got the CE mark.
Article 1
Article2

However, I cannot confirm any information published by the regulatory authorities or Certification body.

P.S. I'm not very good at English, so I'm sorry if I have some impolite or unclear expressions. I welcome any corrections and English review. (You can edit my question and description to improve them)

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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 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.

#,NAME,DEVELOPER,INDICATION,APPROVAL DATE,STATUS,
1,Dectova,GSK,Influenza,Mar-19,Approved,
2,Luxturna,Spark Therapeutics,Retinal dystrophy,Sep-18,Approved,
3,Yescarta,Kite Pharma,Blood cancer,Aug-18,Approved,
4,Kymriah,Novartis,Blood cancer,Aug-18,Approved,
5,Alofisel,TiGenix,Perianal fistulas in Crohn’s disease,Mar-18,Approved,
6,Spherox,CO.DON,Cartilage defects in the knee,May-17,Approved,
7,Zalmoxis,MolMed,Stem cell transplantation in high-risk blood cancer,Jun-16,Approved,
8,Strimvelis,GSK,ADA-SCID,Apr-16,Approved,
9,Imlygic,Amgen,Melanoma,Oct-15,Approved,
10,Holoclar,Chiesi,Severe limbal stem cell deficiency in the eyes,Mar-15,Approved,
11,Provenge,Dendreon,Metastatics prostate cancer,Oct-13,Withdrawn in 2015,
12,MACI,Vericel,Cartilage defects in the knee,Jul-13,Withdrawn in 2014,
13,Glybera,uniQure,Lipoprotein lipase deficiency (LPLD),Nov-12,Withdrawn in 2017,
14,Chondrocelect,TiGenix,Cartilage defects,Nov-09,Withdrawn in 2016,

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.

Spherox and Alofisel, for example, are still in approved status (AUTHORISED) as of November 15, 2020. That can be found in the search results at the following link.

Some of ATMPs have been approved once but were later withdrawn. For example, as of November 15, 2020, MACI has fallen into this category. In fact, a search in the EMA database yields the following results.

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

"WITHDRAWN This medicine is now withdrawn from use in the European Union."

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/".

※.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.

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.

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