Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2012 Feb 14:3:12.
doi: 10.3389/fphar.2012.00012. eCollection 2012.

Advanced Therapy Medicinal Products and Exemptions to the Regulation 1394/2007: How Confident Can We be? An Exploratory Analysis

Philippe Van Wilder  1
Affiliations

Advanced Therapy Medicinal Products and Exemptions to the Regulation 1394/2007: How Confident Can We be? An Exploratory Analysis

Philippe Van Wilder. Front Pharmacol. .

Abstract

The market authorization procedure for medicinal products for human use is relying on their demonstrated efficacy, safety, and pharmaceutical quality. This applies to all medicinal products whether of chemical or biological origin. Since October 2009, the first advanced therapy medicinal product (ATMP) has been authorized through the centralized procedure. ATMPs are gene therapy medicinal products, somatic cell therapy medicinal products or tissue-engineered products. An appropriate ATMP - Regulation is dealing with ATMP requirements. Two exemptions are foreseen to the ATMP Regulation: (a) Products, which were legally on the Community market when the Regulation became applicable, should comply to the Regulation by December 30, 2012. (b) The hospital exemption rule for non-routine products for an individual patient. In this work we explored whether the actual application of the Regulation on ATMPs is in line with the aim of the Regulation in terms of guaranteeing the highest level of health protection for patients. Based on the analysis of the relative efficacy of the only EC authorized ATMP and its exempted alternatives, there is evidence against this Regulation 1394/2007 assumption.

Keywords: Regulation 1394/2007; advanced therapy; exemption; patient outcome.

PubMed Disclaimer

Similar articles

See all similar articles

Cited by

See all "Cited by" articles

References

References from the Pubmed Literature Search

    1. Alberti C. (2009). Tissue engineering technologies: just a quick note about transplantation of bioengineered donor trachea and augmentation cystoplasty by de novo engineered bladder tissue. G. Chir. 30, 514–519 - PubMed
    1. Assche D. V., Caspel D. V., Staes F., Saris D. B., Bellemans J., Vanlauwe J., Luyten F. P. (2011). Implementing one standardized rehabilitation protocol following autologous chondrocyte implantation or microfracture in the knee results in comparable physical therapy management. Physiother. Theory Pract. 27, 125–13610.3109/09593981003681046 - DOI - PubMed
    1. Basad E., Ishaque B., Bachmann G., Stürz H., Steinmeyer J. (2010). Matrix-induced autologous chondrocyte implantation versus microfracture in the treatment of cartilage defects of the knee: a 2-year randomised study. Knee Surg. Sports Traumatol. Arthrosc. 18, 519–52710.1007/s00167-009-1028-1 - DOI - PubMed
    1. Bekkers J. E., Inklaar M., Saris D. B. (2009). Treatment selection in articular cartilage lesions of the knee: a systematic review. Am. J. Sports Med. 37(Suppl. 1), 148S–55S10.1177/0363546509351143 - DOI - PubMed
    1. Brun P., Dickinson S. C., Zavan B., Cortivo R., Hollander A. P., Abatangelo G. (2008). Characteristics of repair tissue in second-look and third-look biopsies from patients treated with engineered cartilage: relationship to symptomatology and time after implantation. Arthritis Res. Ther. 10, R132.10.1186/ar2549 - DOI - PMC - PubMed

References

    1. Basad E., Ishaque B., Bachmann G., Stürz H., Steinmeyer J. (2010). Matrix-induced autologous chondrocyte implantation versus microfracture in the treatment of cartilage defects of the knee: a 2-year randomised study. Knee Surg. Sports Traumatol. Arthrosc. 18, 519–52710.1007/s00167-009-1028-1 - DOI - PubMed
    1. Basad E., Sturz H., Steinmeyer J. (2004). Die behandlung chondraler Defekte mit MACI oder Microfracture-erste Ergebnisse einer vergleichenden klinischen Studie. Orthopadische Praxis. 40, 6–10
    1. Canadian Agency for Drugs and Technologies in Health (2011). Indirect Treatment Comparisons. Accessed September 2. Available at: http://www.cadth.ca/en/products/methods-and-guidelines/publication/884
    1. Clouet J., Vinatier C., Merceron C., Pot-vaucel M., Maugars Y., Weiss P., Grimandi G., Guicheux J. (2009). From OA treatments to future regenerative therapies for cartilage. Drug Discov. Today 14, 913–92510.1016/j.drudis.2009.07.012 - DOI - PubMed
    1. European Commission (2012). Accessed January 2. Available at: http://ec.europa.eu/pharmaforum/docs/final_conclusions_en.pdf

LinkOut - more resources