President of the Pharmaceutical Administration B…

摘要:Traditional Chinese Medicine (TCM) has a long history of use in Macao. Currently, the Macao Special Administrative Region (SAR) go

Traditional Chinese Medicine (TCM) has a long history of use in Macao. Currently, the Macao Special Administrative Region (SAR) government is actively guiding the transformation and upgrading of the TCM health industry, aiming to promote moderate diversification of Macao's economy. Thanks to Macao's unique advantages, the concept of "leveraging Macao to expand overseas" has also become a new opportunity for the development of the TCM industry within the Guangdong-Hong Kong-Macao Greater Bay Area (GBA) and the Chinese mainland. Recently, Yangcheng Evening News interviewed Choi Peng Cheong, President of the Pharmaceutical Administration Bureau of Macao SAR Government.

Industry development cannot thrive without institutional support. In recent years, the Macao SAR government and the Pharmaceutical Administration Bureau have leveraged the advantages of the "One Country, Two Systems" framework to improve various laws and regulations, continuously strengthening the foundation for the development of Macao's TCM health industry.

In terms of scientific research, Macao also has unique advantages. In 2011, the State Key Laboratory of Quality Research in Chinese Medicines, the first national key laboratory in the field of TCM in China, was established in Macao.

For the TCM health industry in Macao, the rapid development of the GBA, especially the accelerated construction of the Guangdong-Macao In-Depth Cooperation Zone in Hengqin, is helping to overcome the industry's development bottlenecks. Choi stated that in 2023, the first traditional Chinese patent medicine (CPM) labeled 'Macao-made' was sold in Macao. We believe that more such medicines will be launched in the future. We hope that businesses will seize the opportunities presented by the development of the Cooperation Zone, fully utilize Hengqin's land, research, and talent resources, and enhance the competitiveness of Macao's TCM industry."

In addition, Macao is actively promoting the use of favorable policies for local TCM products to enter the mainland market. According to Choi, CPM products that have been on the market in Macao for more than five years can enter the Chinese mainland market through a simplified registration and approval process provided by the Guangdong Provincial Drug Administration. Currently, two locally manufactured and sold external CPM products in Macao have received drug registration in the mainland. One of these is a well-known and long-established brand of CPM, while the other entered a Class A tertiary public hospital in the mainland for clinical use last year.

In recent years, the demand for TCM products in overseas markets, particularly in countries along the "Belt and Road" initiative and Portuguese-speaking countries, has been growing rapidly. Choi stated that China has clearly designated Macao's development positioning as "one center, one platform, one base," and with Macao's long-standing active participation in the "Belt and Road" initiative, it will leverage its unique advantages to promote the internationalization of TCM.

"The Bureau will continue to support local pharmaceutical companies in Macao by taking full advantage of the national policies that benefit Macao, as well as utilizing the pilot and production platforms of the Traditional Chinese Medicine Science and Technology Industrial Park of Co-operation between Guangdong and Macao that meet both mainland and EU GMP standards. This will help improve their production capacity and product quality standards. In addition, we will actively promote the GMP construction of local TCM manufacturers, continuously enhancing the level of pharmaceutical production and product quality in Macao, and gradually aligning with international management and technical standards, allowing more Macao-branded products to enter international markets," said Choi. The Bureau is actively guiding local enterprises to align with international standards and have already yielded positive results.

Choi revealed: "The Industrial Park has been actively assisting the industry in expanding TCM service trade to Portuguese-speaking countries. Currently, the Industrial Park has helped several companies successfully export their products to Portuguese-speaking countries, including three products that are manufactured in Macao. Additionally, this year, a Macao-made CPM medicine has also been successfully launched and sold in Singapore."

Looking ahead, Choi stated that Macao will actively utilize platforms such as the Forum on Trade and Economic Cooperation Between China and Portuguese-speaking Countries, as well as the advantage of hosting the permanent secretariat of the Western Pacific Regional Forum for the Harmonization of Herbal Medicine (FHH), to strengthen regional and international cooperation. By doing so, Macao aims to promote TCM products listed in Macao to enter the markets of Portuguese-speaking countries and ASEAN nations, thereby contributing to the development of the "big health" industry.

Source: Lingnan On the Cloud

澳门特区政府药物监督管理局局长蔡炳祥:发展中医药产业 澳门亮出关键招

中医药在澳门有悠久的使用历史。当前,澳门特区政府正积极引导中医药大健康产业转型升级,推动澳门经济适度多元发展。得益于澳门独特优势,“借澳出海”也成为粤港澳大湾区以及内地中医药产业发展的新机会。近日,澳门特区政府药物监督管理局局长蔡炳祥接受了羊城晚报专访。

产业发展离不开制度保障。近年来,澳门特区政府以及特区药物监督管理局,利用“一国两制”的制度优势,完善各项法律法规,持续夯实澳门中医药大健康产业的发展基底。

在科研方面,澳门也有着独特优势。2011年,我国中医药领域首个国家重点实验室——中药质量研究国家重点实验室落户澳门。

对于澳门中医药大健康产业而言,粤港澳大湾区的飞速发展,尤其是横琴粤澳深度合作区的加速建设,有助于澳门中医药大健康产业破解自身发展瓶颈。蔡炳祥表示:“2023年首个‘澳门监制’的中成药在澳门销售,相信将来有更多这类中成药上市。期待企业把握深合区发展的机遇,充分利用横琴的土地、科研及人才资源,提升澳门中药产业的竞争力。”

同时,澳门积极推动本地中医药产品利用好惠澳政策走入内地。据蔡炳祥介绍,澳门已上市5年以上的传统外用中成药,可以通过广东省药监局的简化注册审批程序进入内地市场。目前澳门有两项本地制造及销售的外用中成药取得内地药品注册,其中1项是澳门历史悠久的知名品牌中成药,另1项中成药则在去年进入内地一家三甲公立医院进行临床应用。

近年来,以“一带一路”共建国家和葡语系国家为代表的海外市场对中医药产品的需求与日俱增。蔡炳祥表示,国家明确赋予澳门“一中心、一平台、一基地”的发展定位,同时澳门历来深度参与“一带一路”建设,将充分发挥独特优势,推动中医药国际化。

“药监局会继续支持本澳药企用好国家惠澳政策,利用粤澳合作中医药科技产业园符合内地及欧盟GMP的中试及生产平台,提升其产能及产品质量标准;此外,还会积极推动本澳中药厂GMP建设,不断提升本澳制药水平及产品质量,在管理及技术层面逐步与国际接轨,让更多澳门品牌产品走进国际市场。”蔡炳祥说,澳门特区药监局积极引导本地企业与国际接轨,目前相关工作已收获不错成果。

蔡炳祥透露:“粤澳合作中医药科技产业园一直协助业界拓展葡语系国家的中医药服务贸易,目前产业园已协助多家企业的产品成功出口到葡语系国家,当中有3款产品属于澳门制造。另外,今年一款澳门制造的中成药也成功在新加坡上市销售。”

对于未来,蔡炳祥表示,将积极利用澳门中葡论坛平台,以及西太区草药监管协调论坛(FHH)永久秘书处落户澳门的优势,通过加强区域和国际合作,推动在澳门上市的中药产品进入葡语系国家和东盟国家市场,促进大健康产业发展。

总策划|任天阳

总统筹|林海利

总执行|胡泉

策划执行|蒋铮

统筹执行|王漫琪 李国辉

文丨记者 曾潇 付怡

翻译丨林佳岱

英文审校丨赵凡

来源:羊城派一点号

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