n. dowuona & company’s Post

Recently, I read about the potential impact of the US cannabis industry on European markets, particularly focusing on advanced growing techniques and technological innovations. While the influence of the US industry on Europe is indeed promising, a significant shift in production standards is necessary for successful collaboration. The European Union (EU) maintains rigorous standards, particularly Good Manufacturing Practice (GMP) levels, which are higher than those currently observed in the US. This is not to suggest that US standards are inadequate, but rather that aligning with EU GMP levels would elevate US standards, facilitating smoother trade relations. For US companies to effectively penetrate the European market, they must adhere to these stringent EU GMP standards. The Food and Drug Administration (FDA) standards, while suitable for the US and other countries recognising them, do not fully meet the EU's rigorous requirements. Aligning US standards with EU GMP levels would not only enhance the quality of US products but also open new trading opportunities with the European market. At Haffner International Ltd, we possess a comprehensive understanding of both regions' regulatory landscapes and the necessary steps for US companies to achieve these elevated standards. We are equipped to guide US cannabis companies through the process of obtaining EU GMP certification, ensuring they meet the required levels of quality and compliance. This guidance includes detailed insights into the regulatory expectations and practical steps to elevate production processes to meet EU standards. By bridging the gap between FDA and EU GMP standards, US companies can enhance their market competitiveness and secure a stronger foothold in the European market. This alignment is not only a strategic move for business growth but also a step towards establishing higher global standards within the cannabis industry. #EUGMP #USCannabis #Medicalcannabis #cannabisindustry #haffnerinternationalltd #standards #FDA #EUstandards Picture ©Carl Haffner 2024

After a recent conversation with Pierre van Weperen of GROW® Group PLC and GROW® Pharma , his vision of the United Kingdom’s cannabis market inspired continued rumination on the state of the marketplace and its future directions. For advocates and those in the cannabis industry, cannabis regulation is in constant need of evolution and reform; this is a natural process of a burgeoning market built on decades of suspicion, criminalisation, and prohibition. However, the UK is a unique island of cannabis progress that may or may not improve its regulatory framework soon. Read the latest article by Michael Sassano published in TalkingDrugs: https://lnkd.in/dZKKeYyP  #SOMAÍ #medicalcannabis #medicalcannabismarket #manufacturing #pharmtech #medicalcannabisnews 

Germany's recent legalization of cannabis for recreational use has marked a significant shift in the country's approach to drug policy. While the new law heralds a shift towards liberalization, stringent testing requirements remain essential to uphold product quality and consumer safety. In the wake of this legislative milestone, businesses operating within the burgeoning cannabis market face a pressing need for meticulous testing protocols to meet the demands of German consumers and adhere to European standards. Eurofins Experchem, a leading authority in testing services, underscores the importance of aligning with European Pharmacopoeia (EP) methods to ensure precision and compliance: https://lnkd.in/g3PyGiDd #Eurofins #EurofinsExperchem #Canada #laboratory #testingforlife #qualityassurance #productsafety #cannabistesting

With a nod to Monday's CRS Report about the legal effect of rescheduling on the FDA's Regulation of cannabis, we want to hear your thoughts on federal cannabis regulation. In a perfect world, would you rather see cannabis... 🍻Regulated like alcohol 🍻 In the U.S., alcoholic beverages are regulated at the federal ,state, and local levels. Outside of certain provisions under the FD&C Act which are enforced by the FDA, the Treasury’s TTB plays the biggest role in the regulation of alcohol – from permitting and formulas to labeling and advertising. Federal and state alcohol laws have a 3-tier system that requires a wholesale model and largely prohibits vertical integration. Unlike c”nn”bis, alcohol is not included in the CSA and allows for interstate commerce. Like c”nn”bis, the route to market for alcoholic beverages varies significantly across states. OR 💊 Regulated like pharmaceuticals 💊 Prescription drugs must comply with requirements outlined in both the Controlled Substances Act (CSA) and the FD&C Act. While the DEA is primarily responsible for implementing and enforcing the CSA, most c”nn”bis product forms would be subject to the FD&C Act. By remaining on the CSA, recreational use of these products will remain prohibited. As a Schedule III substance, “interstate commerce” would likely be between pharmacies, not license holders. Let us know in the comments! To read the CRS Report from 9/16/2024, visit: https://smpl.is/9milg #Rescheduling #InterstateCommerce #ThisOrThat #FederalPolicy #CSA #Cannabis #CannabisIndustry

By itself, rescheduling cannabis to a Schedule III drug has no effect on adult use cannabis markets. However, a state regulatory body could (and probably will) require adherence to Current Good Manufacturing Practices as a precondition for obtaining/keeping a business license. The requirements to meet ISO 17025 for a laboratory and CGMP for a cultivation and/or processing facility overlap significantly since the goal for both is Quality! If I were a cultivator, I'd learn the general regulation requirements of 21 CFR 210 & 211 and develop an implementation roadmap. Based on my interactions with a variety of Michigan and California cultivators, most have at least a year of planning ahead. If I were a cannabis testing laboratory, I'd learn about 21 CFR 211.160-180 and develop a roadmap to validating the new revenue streams. #cannabisscience #fdaregulations #cannabisbusiness #cannabiscultivation #laboratoryprofessionals #CGMP

Leave the compliance worries to us in 2024 by subscribing to our monthly HealthRISC: Drug Supply Chain report. With our comprehensive updates, you can navigate the complex regulatory environment with confidence, giving your organization the competitive edge it deserves. Check out a snippet from our most recent report below ⤵️ #REALSolutionsGroup #RSG #GetREAL

The Food and Drug Administration ("FDA") has released draft interim guidance documents regarding bulk drug substances in compounding under Sections 503A and 503B of the FDCA. These documents outline the FDA's historical position and current thinking, stating that new bulk drug substances cannot be used until the FDA completes its review and includes them on a compounding ingredient list. Read a summary of these documents and the implications they will have for compounding entities. #healthlaw #FDA #FDCA #pharmacy

Post-Brexit, the UK's parallel import licensing scheme ensures that a medicine authorized in another EU Member State can be marketed in the UK, provided there is no therapeutic difference from the same UK product. This keeps the market competitive, enabling access to a variety of medicines at reasonable prices. For further information on PI applications, regulatory guidance, and to contact us, reach out to IANUA PHARMA SOLUTIONS at hello@ianuapharmasol.com. #PI #UK #MHRA #IANUA #Medicines #Brexit #guidance #regulatory #contactus

The Food and Drug Administration ("FDA") has released draft interim guidance documents regarding bulk drug substances in compounding under Sections 503A and 503B of the FDCA. These documents outline the FDA's historical position and current thinking, stating that new bulk drug substances cannot be used until the FDA completes its review and includes them on a compounding ingredient list. Read a summary of these documents and the implications they will have for compounding entities. #healthlaw #FDA #FDCA #pharmacy

As the cannabis industry continues to scale, more plants are being cultivated and processed than ever before to meet corresponding product demand. 📈 The growth in the industry highlights the paramount role that GxP plays in ensuring the quality, safety, and efficacy of cannabis products. But what is GxP? 🤔 Expert Patrick Bird explains in his article for Cannabis Science and Technology: https://lnkd.in/gVQ_68sg? #CannabisIndustry #CannabisBusiness