RE: SAMR19 Feb 2023 08:18
November 2016: Strategic collaboration agreement announced for Fruitflow® between DSM and BYHEALTH
April 2017: MOU for a research and collaboration agreement announced for Fruitflow® between the Provexis and BY-HEALTH. BY-HEALTH plans to launch a number of Fruitflow® based products in the Chinese market, first launch envisaged in the second half (Dec) of 2017.
Sept 2018: Its announced that B-H are conducting 6 studies, at their sole expense, for Fruitflow and ‘blue cap’ health claim status, as required by the China Food and Drug Administration (CFDA), with BY-HEALTH intending to make the relevant submission to the CFDA by the end of 2018.
Sept 2021: its announced that:- By-Health is now working on an extensive regulatory submission to the SAMR for Fruitflow, seeking to establish a new permitted health function claim for food ingredients such as Fruitflow that can demonstrate an anti-platelet effect, addressing the aberrant blood clots which can lead to heart attacks and strokes .By-Health currently expects to be in a position to complete the last of its eight studies and file its regulatory submission to the SAMR for Fruitflow in the first half of 2022.
Sept 2022: By-Health continues to work on an extensive regulatory submission to the Chinese State Administration
for Market Regulation (SAMR) for Fruitflow, seeking to establish a new permitted health function claim for
foods such as Fruitflow that can demonstrate an anti-platelet effect, addressing the aberrant blood clots
which can lead to heart attacks and strokes.
July, 2016: China Food and Drug Administration (CFDA) published the formal “Administrative Measures on Health Food Registration and Filing”(Hereinafter called “new Administrative Measures”) which will replace the “Administrative Measure on Health Food Registration (Trial) (Order No.19)”, meanwhile, come into force on 1 July, 2016.
Once the new Administrative Measures implemented, there will be two kinds of policy (registration and filing) for health food produced or marketed in China.
April 2018: the State Administration for Market Regulation was formally established. On April 10, 2018
So..... not only has B-H gone from launching products to getting Blue Cap to getting a permitted health function claim there has also been a massive restructuring of the Chinese regulatory system not to mention probably major delays with trials because of the lock down measures in China.
Having a permitted health function claim will substantially increase the potential revenue that Fruitflow can achieve For B-H/PXS and if you go back to 2016 it was not possible, due to the regulations at the time, for B-H to submit such a claim.
Now to answer your question . "why it is taking so long?"
As the regulatory system has been changing in China so has B-Healths plans. The end result being greater revenue potential for Fruitflow.
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