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Hemp for INDs

 

FDA Cannabis Derived Product Develop Guidance encourages sponsors to develop hemps to prescription medicines through FDA botanical drug regulatory filing. Hemp is defined as "dry weight of THC < 0.3%".

  • IND is the process to promote medical benefit

  • Hemp can be mixed with other botanical products, No further purification is required

  • No need to describe mechanism of action

  • No need to identify active ingredient

As long as the drug product demonstrate safety and efficacy in phase 1,2,3 trials, it is approved as a prescription drug on the US market

Mission

     The global market for botanical and plant-derived drugs expected to grow to $39.6B by 2022 with a compound annual growth rate (CAGR) of 6.1%. The US FDA Botanical Drug Development Guidance for Industry defines a pathway for herbal medicines and cannabis derived products to become prescription drugs in the US.

     The American Botanical Drug Association is an industry organization for world wide herbal and cannabis companies, with a mission to:

  • Increase public awareness of botanical drugs

  • Increase options in the healthcare system

  • Facilitate healthcare policy formation

  • Serve as a platform for dialogues and collaboration among government agencies, private enteritis, and academics, by means of conferences and meetings

  • Promote collaboration between the pharmaceutical industry and the botanical and herbal industry

  • Establish international standards for botanical drugs and its medical usage​

ABDA collaborates with research institutes and companies to develop safe and efficacious botanical products to prescription botanical drugs through FDA botanical drug development pathway.

 
 

Background
     The pharmaceutical industry has been thriving for many decades but experienced inevitable slowdown in recent years. Chemical drugs are limited in certain disease areas, like virus-induced infection. An alternative approach for drug development is needed.  The US FDA ”Botanical Drug Development Guidance for Industry" opens doors for botanical products like herbal medicines or cannabis derived products to be developed as prescription drugs: if a drug product is derived from single plant or from mix of plants, the Guidance waives the requirement of: 1) identifying active ingredients, 2) description of mechanism of action. As long as a botanical product demonstrates safety and efficacy in phase 1, phase 2, and phase 3 trials, they are approved as a prescription drugs on the US market. Two botanical products have been approved so far as prescription drugs:

  • Veregen (sinecatechins), a topical drug for the treatment of genital and perinatal warts.

  • Fulyzaq (crofelemer), an oral drug for control and symptomatic relief of diarrhea in patients with HIV/AIDS on anti-retroviral therapy.

     Between 2016 to 2019, 195 botanical drug clinical trials were registered, of which 81 are phase 2 or 2/3. By the end of 2018, over 800 IND applications were filed to US FDA under the botanical drug category. The majority of them were allowed to the clinical trial stage.  ABDA's mission is to facilitate the development of botanical drug industry.

 
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Focus

     Modern herbal medicines are in forms of pills or capsules. Their safety and efficacy have been demonstrated by daily use on large scale population. Identifying already-known effective herbal medicines with promising indications on the US market is an efficient drug development pathway. ABDA promotes US FDA botanical drug guidance and collaborates with entities around the globe to develop herbal medicines to US botanical drugs.

     FDA issued a draft Cannabis Product GFI to encourage cannabis derived products to develolp into prescription drugs through FDA Botanical Drug Development GIF.

    ABDA develops research platform for scientists around the globe to work together to advance technology application in herbal medicine research.

    By working with research institutions and entities around the world, ABDA develops and publish industry standards.

 
 

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