Tissue Therapies Limited ABN 45 101 955 088...

Tissue Therapies Limited ABN 45 101 955 088 www.tissuetherapies.com
Level 19, 179 Turbot Street, Brisbane QLD 4000 Australia
GPO Box 1596 Brisbane QLD 4001
telephone +61 7 3334 3900 facsimile +61 7 3334 3999
12338179v1 |
ASX ANNOUNCEMENT
29 July 2013
Appendix 4C Quarterly Report and CE Mark Update
Since the unexpected advice received from the European Medicines Agency (EMA)
(please see, ASX: TIS “Regulatory Update”, 18 March 2013.), the Company has
made substantial progress towards being granted CE Mark for VitroGro® ECM.
Immediately following the notification from the EMA that it had conducted an “informal
survey” summarised in the announcement of 18 March 2013, Tissue Therapies initiated
an intense series of consultations and meetings with the Notified Body (BSI), the UK
health regulatory agency, the MHRA, and the EMA.
Assisting Tissue Therapies in this has been a small team of expert health regulatory
and health law advisors engaged by the Company to resolve what is a highly unusual
regulatory situation. The progress that has been made so far includes:
• confirmation from specialist regulatory lawyers including a QC that the EMA
“informal survey” of members has no statutory basis under European
Commission (EC) law or European Union (EU) regulatory procedures
• confirmation by the Head of the EC Legal Affairs Unit that,
“… neither the European Commission nor the EMA are competent bodies to
issue opinions or legally binding decisions on the classification of a product as a
medical device.” The UK health regulatory agency the MHRA is the “competent
body”.
• after independently conferring with the EC Legal Affairs Unit, the EMA has now
confirmed to Tissue Therapies that it will reconsider its position i.e. proceed with
the manufacturing data review upon receiving written confirmation of the
classification of VitroGro® ECM as a device by the MHRA.
• Tissue Therapies requested the MHRA as a matter of urgency to provide this
confirmation. After market close in Australia on Friday 26 July 2013, the MHRA
confirmed by letter to both Tissue Therapies and BSI that VitroGro® ECM is
classified as a device. The Company has forwarded the MHRA classification
confirmation letter to the EMA.
Tissue Therapies Limited ABN 45 101 955 088 www.tissuetherapies.com
Level 19, 179 Turbot Street, Brisbane QLD 4000 Australia
GPO Box 1596 Brisbane QLD 4001
telephone +61 7 3334 3900 facsimile +61 7 3334 3999
12338179v1 | 2
The MHRA confirmed the final classification of VitroGro® ECM as a device
during late October 2012. (Please see ASX: TIS “VitroGro® ECM Medical
Device Classification Confirmed”, 30 October 2012.)
While a firm timetable for the data review by the EMA and granting of CE Mark has not
yet been established, a clear process to achieve CE Mark has now been provided by
the MHRA and EMA.
The EMA review of manufacturing quality data is the last step in the process of granting
CE Mark and the start of sales. This data review is a desk audit for which Tissue
Therapies is well prepared.
As was included in the announcement on 18 March 2013, an independent, expert
review of the Company’s regulatory affairs procedures was commissioned and has now
been completed. The formal report of this investigation has been delivered to the UKbased
independent director of Tissue Therapies, Mr Iain Ross. This report concluded
that:
• “The chain of events leading to the EMA evaluating the classification of
VitroGro® ECM could not have been predicted from the outset.”, and;
• “In conclusion the company have acted appropriately and continued development
of the product as a device in good faith.”
Further information on the timetable for the completion of the processes for the granting
of CE Mark and start of sales in the EU will be announced as soon as it is received.