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Canadian Special Access Program Further Authorizes Novel Psychedelic Drugs For Emergency Treatments
Canadian Special Access Program Further Authorizes Novel Psychedelic Drugs For Emergency Treatments
For those unaware, Canada provides a legal way for patients presenting unresolved mental health issues to receive psychedelic-assisted treatment. While the country still has not provided legal status to psychedelics, recent amendments have made it possible for health practitioners to request permission to access restricted drugs for patients with serious or life-threatening conditions for whom other therapies have proven unsuitable or failed.
The authorization, granted by Health Canada through its Special Access Program, is therefore strictly related to each patient's situation, on a case-by-case basis, while also considering the level of scientific evidence, including that pertaining to safety and efficacy, to support the drug's use for the treatment of each patient's specific condition.
As reported by the Canadian government's official newspaper, requests to the Special Access Program (SAP) are normally only considered when positive results of Phase 2 or Phase 3 (the highest stage a drug can achieve in clinical research before aiming for legal approval) clinical trials are already available.
The process goes as follows: When the SAP authorizes the sale of a specified quantity of an unapproved -and unmarketed- drug, the requesting practitioner must provide the name and the civic address of the facility to which the drug will be shipped. The person who receives the shipment of the drug must be a practitioner or a pharmacist.
It is also worth noting that practitioners who initiate requests on behalf of their patients are responsible for ensuring that they are informed of all possible risks and benefits of the drug being requested as well as its development status.
After the drug-assisted therapy, health practitioners must complete a reporting form including dose alteration (if applied), treatment response, general outcomes and adverse reactions.
The newest drug candidate to be granted permission for treatment is a proprietary compound of Filament Health Corp. (OTCQB:FLHLF), a clinical-stage natural psychedelic drug development company. Market authorization of Filament's drug candidates has not yet been granted by Health Canada or any other health authority.
Recently, a press release by Braxia Scientific Corp. (OTC:BRAXF) reported positive results from its multi-dose psilocybin trial will most likely facilitate psilocybin prescription through the Health Canada Special Access Program by physicians on a case-by-case basis to patients in need.
Earlier this year, synthetic psilocybin (donated by the Canadian biotech company Apex Labs) was used in combination with psychotherapy for six patients experiencing end-of-life distress. This was the first known case of psilocybin being approved through Canada's SAP since the January amendments to the Food and Drug Regulations.
Photo Courtesy of ELG21 on Pixabay.
For those unaware, Canada provides a legal way for patients presenting unresolved mental health issues to receive psychedelic-assisted treatment. While the country still has not provided legal status to psychedelics, recent amendments have made it possible for health practitioners to request permission to access restricted drugs for patients with serious or life-threatening conditions for whom other therapies have proven unsuitable or failed.
对于那些不知情的人,加拿大为出现未解决的精神健康问题的患者提供了接受迷幻辅助治疗的合法途径。虽然该国仍未向致幻剂提供法律地位,但最近的修正案使卫生从业者有可能申请许可,允许患有严重或危及生命的患者获得限制药物,而其他疗法已被证明不适合或失败。
The authorization, granted by Health Canada through its Special Access Program, is therefore strictly related to each patient's situation, on a case-by-case basis, while also considering the level of scientific evidence, including that pertaining to safety and efficacy, to support the drug's use for the treatment of each patient's specific condition.
授权,由授予加拿大卫生部通过ITS特别访问计划因此,在个案的基础上,严格地与每个患者的情况有关,同时也考虑到科学证据的水平,包括与安全性和有效性有关的证据,以支持该药物用于治疗每个患者的具体情况。
As reported by the Canadian government's official newspaper, requests to the Special Access Program (SAP) are normally only considered when positive results of Phase 2 or Phase 3 (the highest stage a drug can achieve in clinical research before aiming for legal approval) clinical trials are already available.
正如加拿大政府官方报纸报道的那样,向特别准入计划(SAP)提出的请求通常只有在以下情况下才会被考虑第二阶段或第三阶段(一种药物在获得法律批准之前在临床研究中可以达到的最高阶段)已经可以进行临床试验。
The process goes as follows: When the SAP authorizes the sale of a specified quantity of an unapproved -and unmarketed- drug, the requesting practitioner must provide the name and the civic address of the facility to which the drug will be shipped. The person who receives the shipment of the drug must be a practitioner or a pharmacist.
程序如下:当SAP授权销售特定数量的未经批准和未上市的药物时,提出请求的从业者必须提供药物将运往的机构的名称和公民地址。收到药品的人必须是从业者或药剂师。
It is also worth noting that practitioners who initiate requests on behalf of their patients are responsible for ensuring that they are informed of all possible risks and benefits of the drug being requested as well as its development status.
还值得注意的是,代表患者提出申请的从业者有责任确保他们被告知所申请药物的所有可能的风险和益处以及其开发状况。
After the drug-assisted therapy, health practitioners must complete a reporting form including dose alteration (if applied), treatment response, general outcomes and adverse reactions.
在药物辅助治疗后,卫生从业者必须填写一份报告表,包括剂量改变(如果适用)、治疗反应、一般结果和不良反应。
The newest drug candidate to be granted permission for treatment is a proprietary compound of Filament Health Corp. (OTCQB:FLHLF), a clinical-stage natural psychedelic drug development company. Market authorization of Filament's drug candidates has not yet been granted by Health Canada or any other health authority.
获得治疗许可的最新候选药物是一种专有的化合物灯丝健康公司(OTCQB:FLHLF),一家临床阶段的天然迷幻药物开发公司。加拿大卫生部或任何其他卫生当局尚未批准对该药候选药物的上市授权。
Recently, a press release by Braxia Scientific Corp. (OTC:BRAXF) reported positive results from its multi-dose psilocybin trial will most likely facilitate psilocybin prescription through the Health Canada Special Access Program by physicians on a case-by-case basis to patients in need.
最近,一份新闻稿由布拉夏科学公司(场外交易代码:BRAXF)据报道,其多剂量裸盖菇素试验的阳性结果将极有可能促进医生通过加拿大卫生部特别准入计划向有需要的患者开出裸盖菇素处方。
Earlier this year, synthetic psilocybin (donated by the Canadian biotech company Apex Labs) was used in combination with psychotherapy for six patients experiencing end-of-life distress. This was the first known case of psilocybin being approved through Canada's SAP since the January amendments to the Food and Drug Regulations.
今年早些时候,合成裸盖菇素(由加拿大生物技术公司捐赠顶尖实验室)与心理治疗相结合,用于六名经历临终痛苦的患者。这是自1月份修正案以来,已知的第一例裸盖菇素通过加拿大SAP获得批准《食品和药物条例》.
Photo Courtesy of ELG21 on Pixabay.
图片由ElG21在Pixabay上提供。
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在美国,moomoo上的投资产品和服务由Moomoo Financial Inc.提供,一家受美国证券交易委员会(SEC)监管的持牌主体。 Moomoo Financial Inc.是金融业监管局(FINRA)和证券投资者保护公司(SIPC)的成员。
在新加坡,moomoo上的投资产品和服务是通过Moomoo Financial Singapore Pte. Ltd.提供,该公司受新加坡金融管理局(MAS)监管(牌照号码︰CMS101000) ,持有资本市场服务牌照 (CMS) ,持有财务顾问豁免(Exempt Financial Adviser)资质。本内容未经新加坡金融管理局的审查。
在澳大利亚,moomoo上的金融产品和服务是通过Futu Securities (Australia) Ltd提供,该公司是受澳大利亚证券和投资委员会(ASIC)监管的澳大利亚金融服务许可机构(AFSL No. 224663)。请阅读并理解我们的《金融服务指南》、《条款与条件》、《隐私政策》和其他披露文件,这些文件可在我们的网站 https://www.moomoo.com/au中获取。
在加拿大,通过moomoo应用提供的仅限订单执行的券商服务由Moomoo Financial Canada Inc.提供,并受加拿大投资监管机构(CIRO)监管。
在马来西亚,moomoo上的投资产品和服务是通过Moomoo Securities Malaysia Sdn. Bhd. 提供,该公司受马来西亚证券监督委员会(SC)监管(牌照号码︰eCMSL/A0397/2024) ,持有资本市场服务牌照 (CMSL) 。本内容未经马来西亚证券监督委员会的审查。
Moomoo Technologies Inc., Moomoo Financial Inc., Moomoo Financial Singapore Pte. Ltd., Futu Securities (Australia) Ltd, Moomoo Financial Canada Inc.,和Moomoo Securities Malaysia Sdn. Bhd.是关联公司。
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moomoo是Moomoo Technologies Inc.公司提供的金融信息和交易应用程序。
在美国,moomoo上的投资产品和服务由Moomoo Financial Inc.提供,一家受美国证券交易委员会(SEC)监管的持牌主体。 Moomoo Financial Inc.是金融业监管局(FINRA)和证券投资者保护公司(SIPC)的成员。
在新加坡,moomoo上的投资产品和服务是通过Moomoo Financial Singapore Pte. Ltd.提供,该公司受新加坡金融管理局(MAS)监管(牌照号码︰CMS101000) ,持有资本市场服务牌照 (CMS) ,持有财务顾问豁免(Exempt Financial Adviser)资质。本内容未经新加坡金融管理局的审查。
在澳大利亚,moomoo上的金融产品和服务是通过Futu Securities (Australia) Ltd提供,该公司是受澳大利亚证券和投资委员会(ASIC)监管的澳大利亚金融服务许可机构(AFSL No. 224663)。请阅读并理解我们的《金融服务指南》、《条款与条件》、《隐私政策》和其他披露文件,这些文件可在我们的网站 https://www.moomoo.com/au中获取。
在加拿大,通过moomoo应用提供的仅限订单执行的券商服务由Moomoo Financial Canada Inc.提供,并受加拿大投资监管机构(CIRO)监管。
在马来西亚,moomoo上的投资产品和服务是通过Moomoo Securities Malaysia Sdn. Bhd. 提供,该公司受马来西亚证券监督委员会(SC)监管(牌照号码︰eCMSL/A0397/2024) ,持有资本市场服务牌照 (CMSL) 。本内容未经马来西亚证券监督委员会的审查。
Moomoo Technologies Inc., Moomoo Financial Inc., Moomoo Financial Singapore Pte. Ltd., Futu Securities (Australia) Ltd, Moomoo Financial Canada Inc.,和Moomoo Securities Malaysia Sdn. Bhd.是关联公司。
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