Biliflow tablets were successfully exported to Canada and Hutchison Pharmaceutical realized the dream of Chinese medicine internationalization

On October 14, Biliflow (Canadian trade name: Biliflow) held a loading and delivery ceremony
at the Fengpu R&D and production base of Shanghai Hehuang Pharmaceutical.
The batch of drugs will be sent to international logistics carriers, and will sail to Toronto
, Canada on October 21.
This marks that Shanghai Hehuang Pharmaceutical, as a licensee, manufacturer and exporter, has officially entered the international mainstream drug market as a drug and realized the last step in the whole process of internationalization of traditional Chinese medicine, which is of milestone demonstration significance
for the internationalization of traditional Chinese medicine.

Group photo of the loading and delivery ceremony of the tablets exported to Canada

In 2014, Shanghai Hutchison Pharmaceutical promoted the international registration
of cholining tablets on the basis of the modernization of traditional Chinese medicine.
After full analysis and demonstration, the registration path of "pharmacopoeia medicinal materials - pharmacopoeia varieties - traditional medicines, based on domestic evidence" was selected, and after 15 months of preparation, preparation and translation of nearly 100 registration application materials, and many times of communication with Health Canada, the registration application was officially submitted to Health Canada in September 2016, and then passed the expert review, official announcement and other approval processes at one time.
On December 15, 2016, it successfully obtained the marketing authorization of natural medicines in Canada (NPN: 80073325).

Immediately afterwards, Shanghai Hutchison Pharmaceutical proposed requirements
for the certification of production sites outside Canada.
In October 2018, Health Canada experts came to China for academic exchanges and inspected the production site of Shanghai Hehuang Pharmaceutical, and the experts praised
the modern production site conditions of Cholining tablets 。 After providing more than 180 certification application materials as required, on July 12, 2019, Shanghai Hutchison Pharmaceutical obtained the certification of overseas production sites in Canada (FSRN: 5000525), taking the lead in becoming a traditional Chinese medicine manufacturer in China issued by Health Canada with FSRN certification, and passed the overseas site certification re-inspection for two consecutive years in 2020 and 2021, providing good quality assurance and basic conditions
for the export of bione tablets.

In the context of the international epidemic, Shanghai Hutchison Pharmaceutical overcame many difficulties and tried to sell in Canada through the Amazon cross-border e-commerce platform, but finally chose to cooperate
with importers who can land in Canada.
With the common vision of "internationalization of traditional Chinese medicine", the two parties completed the signing of a three-year sales agreement during the epidemic lockdown management in Shanghai on April 8, 2022, and completed the signing
of the first batch of export contracts for cholening tablets on July 18.

In order to adapt to the characteristics of the Canadian drug market and quickly open the situation of sales of bile tablets in Canada, Shanghai Hehuang Pharmaceutical has carefully designed the packaging of the export products of bile tablets to make its content meet the regulatory requirements of Health Canada, and the appearance is more European and American style
.

The road to sea has not been easy
.
A Canadian importer's holding of a Site Licence is a requirement to be eligible for the import of variety, and the FSRN should be included in the importer's Site Licence
。 However, in the process of importers applying for a variety-linked Site Licence, Health Canada issued the document "Refusal criteria for submissions for a site licence and foreign site reference number" on August 19, which mentioned that if the importer does not produce an actual import business for the variety within 12 months after obtaining the Site Licence, Applications for a Site Licence will be rejected
.
On September 17, the importer received the Notice of Sampling Results Request (IRN) from Health Canada, requiring our company to supplement the API analysis certificate and batch production records within 5 working days, improve the quality standards in accordance with USP (United States Pharmacopoeia) requirements, and provide complete reports and materials
such as 70 pesticide residue test results.
With the cooperation of relevant departments, the international registration team of Shanghai Hehuang Pharmaceutical worked overtime to complete the task, submitted hundreds of pages of English materials on September 23, and assisted the importer to successfully obtain the variety association site license
on October 8.

Hutchison Pharmaceutical International Registration Core Team

70 pesticide residue test reports (USP compliant)

In order to ensure the smooth export of Chuan Ning tablets, the company's production center, quality center, marketing department, procurement and supply department have given full support and cooperation, reflecting the pursuit of excellence and Huang spirit and culture
.
At the loading and delivery ceremony of Cho Ning tablets exported to Canada, Zhan Changsen, vice president of R&D, asked everyone to remember that October 14, 2022 is the day when Shanghai Huthuang Pharmaceutical Co.
, Ltd.
realized its dream of "internationalization of traditional Chinese medicine", which is the result of years of persistence, multi-party efforts and the hard work of
the core registration team.

Zhou Junjie, president of the company, finally spoke, saying: Today is a milestone in the internationalization of Chu Ning Films, which is of special commemorative significance
to Hehuang people and everyone who cares about the internationalization of Chu Ning Tablets.
We would like to thank Zhongguancun Modern Medicine Productivity Promotion Center, especially Director Bai Jian, for their years of cooperation and efforts; Thanks to the internationalization team at the Technical Center and all the employees
who contributed to it.
Over the years, we have been adhering to the application of scientific inquiry and interpretation of the clinical value of Chinese medicine, and strive to
achieve the goal of modernization and internationalization of Chinese medicine.
Today we have finally achieved our milestones
.
In the future, we will continue to inherit the classics, keep the integrity and innovation, and make new contributions
to the modernization and internationalization of traditional Chinese medicine.