Psychedelics

Press Release: PSYC Provides Shareholders with Key Corporate Updates and Highlights Objectives for 2023

Published

2 years ago

February 1, 2023

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LAS VEGAS, NV, Jan. 31, 2023 (GLOBE NEWSWIRE) — PSYC Corporation (OTC Pink Market: PSYC) (“PSYC”, “PSYC Corp” or the “Company”), parent company to Spotlight Media Corporation (“SMC” or the “wholly owned subsidiary”), a multimedia leader positioned at the intersection where all things psychedelics and cannabis converge, is pleased to provide its shareholders with an overview of recent key corporate updates along with insight into some of the prime objectives the Company is outlining for the year ahead.

Sacha G. Hebbert Joins the PSYC Board

As of this month, the Company is proud to have appointed Sacha G. Hebbert to its Board of Directors alongside PSYC CEO, David Flores and PSYC COO, Michael Berger. In addition to her appointment on the Company’s Board, Ms. Hebbert has also been appointed to the position of Chief Brand Officer (“CBO”) for PSYC Corp and will continue to maintain her position as Chief Operating Officer of the Company’s wholly owned subsidiary, Spotlight Media Corporation (“SMC”).

In her added role as CBO of the parent company, Ms. Hebbert will work in close collaboration with Mr. Flores and Mr. Berger with the ongoing development of PSYC’s brand and image as an evolving publicly traded multimedia leader for the emerging psychedelics sector, and with the objective of helping to identify opportunities to strengthen shareholder value.

Additionally, Ms. Hebbert will continue to play a pivotal leadership role with developing and implementing critical strategies designed to maximize the value of the Company’s current psychedelic-focused media assets operated under SMC such as Psychedelic Spotlight and Bonfire.

“My goal is to ensure that Psychedelic Spotlight continues to grow in domain authority. We’re currently ranked high amongst the top 5 psychedelic media outlets. By the end of this year, I see us in the number one position. Those investing in PSYC will be happy to know that Psychedelic Spotlight is well-positioned as a culture shaper and media partner to the entire B2C market. We continue to tap into the mainstreaming of psychedelics and attract a substantial and curious audience to our platform through provocative and informative content. We’re also building traffic toward Bonfire, our burgeoning community of psychedelic facilitators and seekers. These two platforms, together, create the perfect funnel for service and product providers and consumers in this growing market. By the end of next quarter, we should see a lot of action on our Bonfire platform as we align with strategic partnerships that expand concrete revenue generators.”

Integration of Newly Acquired Media Assets

In September of last year, the Company acquired Technical 420, On The Bids, and Mushroom Stocks from Technical420, LLC. In the months following the acquisition of these media assets, the Company dedicated considerable time to successfully integrating them into SMC as key revenue drivers for the Company.

These efforts, spearheaded by PSYC Chief Operating Officer and SMC Chief Revenue Officer, Michael Berger, have resulted in a steady increase in revenue generation for the Company, which it claims to be reflected as such in it’s soon-to-be-published 2022 annual disclosure and financials. During Q4 of 2022, the Company experienced its strongest revenue performance throughout all of 2022, with approximately $60K generated in gross revenue.

Plans through the first two quarters of 2023 are to continue to implement strategies that are primarily focused on expanding revenue generation capabilities of both Technical 420 and On The Bids. The Company contends that in the months following the acquisition, each of these platforms have emerged as primary revenue drivers for the Company by way of valuable investor and public relations-focused services provided to various publicly traded companies operating in thriving industries such as cannabis and mining and precious metals and where many companies are actively seeking the opportunities to enhance their exposure across the public markets – a key value point offered by Technical 420 and On The Bids.

Furthermore, in the months ahead, the Company plans to apply many of the elements that have have driven the success, from a revenue generation and client satisfaction standpoint, for both Technical 420 and On The Bids over into Mushroom Stocks, and particularly as public companies operating in the psychedelics sector are expected to begin to ramp investor awareness efforts back up throughout 2023.

PSYC COO Michael Berger said, “During the last quarter, our primary objectives have been centered around integrating the business units, finding synergies, and becoming cash flow positive. Since the completion of the acquisition, our websites have generated more than $100,000 of revenue and have secured approximately $75,000 in equity-based agreements. Although market conditions are challenging, we have been able to penetrate new verticals in a cost-efficient manner. We remain bullish on the cannabis and psychedelic industries and believe we have the assets and resources to achieve our primary objectives. Over the next year, we plan to establish Spotlight Media Corp as a media leader in several burgeoning industries and I am confident in our ability to do so.”

Updates on Bonfire and Psychedelic Finder

Following more than 5 months of market testing on the current Bonfire platform, the Company, along with its partner in the project, Digital Acorn, Ltd., has opted to revisit the core fundamentals associated with the platform and with the intent of identifying and developing a more cost effective operations model for the platform, in addition to a more robust and refined monetization strategy that will be more effectively suited for scalability.

The pause on the current iteration of the platform coincides with the resignation of Jack Bunce this month who, over the last several months, had overseen the operations of the Bonfire platform.

In the coming weeks, the Company will work in collaboration with Digital Acorn to identify and select a new leadership team that will focus on successfully ushering Bonfire into the next phase of redevelopment.

The Company contends, however, that it remains cautiously optimistic as to the future potential of Bonfire citing valuable data and information it was successful in gathering throughout the market test phase that, according to the Company, reflects significant market interest in a platform designed with the intent of building a community centered around psychedelic integration.

With regard to Psychedelic Finder, the Company, along with its partners in the project, Nucleus Holding Inc., remain focused and committed to building out this platform which will be an online resource assisting those looking for treatment and care providers.

The companies, however, have agreed to push the official launch of the platform back into later in 2023 as they collectively focus on raising additional capital that will be required to bring some of the intricate details proposed for the platform to fruition.

The companies are intent on bringing to market a platform that goes far beyond what other, similar platforms, operating in this space currently offer.

The Company plans to continue to provide updates on the progress of both Bonfire and Psychedelic Finder in the weeks and months ahead.

Psychedelic Spotlight Continues to Thrive Under a Leaner, More Efficient Business Model

Coming into 2023, PSYC Management made the collective decision to implement various strategic updates to the operational structure of Psychedelic Spotlight. At the core of these updates, was developing a cost-effective plan that will continue to promote the growth of the platform, but under a leaner, and more efficient business model.

Over the course of 2022, PSYC was successful in establishing Psychedelic Spotlight as a top 5 media platform focused exclusively on psychedelics. According to the Company, this top 5 ranking is based on website performance data and analytics gathered from Google such as page views, site visits, and engagement, amongst other metrics.

The Company contends that these metrics play a vital role, as is typically the case with most media platforms, in the ability to monetize the platform through advertisement, sponsorship, and partnership opportunities, and views their current ranking as a competitive advantage in a marketplace that is becoming increasingly competitive.

Since implementing many of the aforementioned updates to the Psychedelic Spotlight business model at the start of the new year, which includes operating the platform with a leaner budget, the Company claims that the metrics tied to its website performance have not dropped off and in fact, the platform continues to hold steady amongst its top competitors and is even demonstrating growth in critical areas such as organic search. This, according to the Company, can be viewed as a demonstration of the success in some of the strategic and hyper-focused growth initiatives Psychedelic Spotlight Director of Marketing, Maria Holyanova, has recently implemented.

The Company plans to continue prioritizing the growth of Psychedelic Spotlight throughout 2023, and while it cannot offer any guarantees, the Company remains committed and highly optimistic in its objective of establishing it as the number one media platform for the emerging sector of psychedelics in the most reasonable time frame possible.

Closing Comments from PSYC CEO, David Flores

“In 2022, we witnessed the culmination of so much of the hard work we had been focused on over the previous two years in terms of developing PSYC into a formidable multimedia leader for psychedelics and other forward-thinking industries such as cannabis. We managed to grow Psychedelic Spotlight into a top 5 media platform for the growing sector of psychedelics, and we brought in new media assets that in addition to providing us with very valuable elements of diversification, have also created a steady, and much-needed revenue stream for us.

The objective here in 2023 is to take what we successfully accomplished last year and expand on it. Cracking the top 5 as a psychedelic’s media platform is a wonderful accomplishment, but make no mistake about it, we aspire to be number one. Bringing in assets that are revenue generating is, in my opinion, a huge step forward for us, but some revenue doesn’t equate to a viable path to profitability, so we’re laser focused on generating even more revenue.

From my perspective, all of these are very important fundamentals that we are meticulously moving into place as part of what we view as a much bigger objective for PSYC. They’re also lending to our ability to have real and very serious conversations related to potential value-driven partnership opportunities and even capital investment opportunities that we simply couldn’t have in years past.

Acquiring what is still, in my opinion, the best ticker symbol for a publicly traded company operating in the psychedelics sector (PSYC), was done so with the intention of developing PSYC into something much more than just another multimedia company operating in the psychedelics space. It was done with the intention of building PSYC into the multimedia company for psychedelics. And as we approach the 3-year mark of the commencement of this journey, this intention, from my perspective, and based on the fundamentals we have put into place, remains as attainable as ever.

There are still many challenges that lie ahead for us in order to earn the trust and credibility within the public markets that we believe is necessary to drive and deliver maximum shareholder value. But what I can assure you is that I, along with the newly formed board of directors and the incredibly talented and dedicated management team we have assembled for the Company, are working tirelessly each and every day to develop solutions that are aimed specifically at overcoming these challenges in the most reasonable manner and time frame possible.

Thank you to all the PSYC shareholders who continue to stand alongside us on this journey. We see you. We hear you, and we are committed to doing everything we can to return the value back to you that we believe you deserve.

About PSYC Corporation (OTC Pink Market: PSYC)
At PSYC Corporation we are integrating media, creativity, and technology to develop and deploy thought-provoking ideas and solutions that are fostering and transforming the approach to some of society’s most pressing matters.

PSYC has expressed its intent and commitment to positioning itself at the forefront of the psychedelic revolution and as a resource center for discovering and understanding the latest research and business opportunities surrounding psychedelic inspired medicines. In conjunction with the FDA’s more open-minded approach to psychedelic medicines, and as several major U.S. cities continue to approve the decriminalization of psilocybin, we believe investors are speculating that the psychedelic boom could be bigger than that of cannabis. PSYC is your source for current investment related news specific to psychedelic medicines and cutting-edge research improving overall health, moving this sector into the mainstream.

We are dedicated to a forward-thinking approach that embraces groundbreaking new technology and innovations and through the vision of business development we intend to continue to evolve into these unchartered territories as the industry leaders of the future.

About Spotlight Media Corporation

Spotlight Media Corporation (“SMC”) (www.spotlightmediacorp.com) is a Nevada Corporation and is a privately held wholly owned subsidiary of PSYC that was incorporated on February 8, 2022. At present time, SMC operates as a multimedia service company for the medicinal psychedelic industry through Psychedelic Spotlight in addition to the developing community-based platform, Bonfire (f/k/a “PsycheDev”). However, management intends, but cannot guarantee the success or profitability, that the business plan for SMC is to potentially expand beyond the medicinal psychedelic industry by way of other multimedia-related opportunities within other niche-style industries like cannabis, health and wellness, and sports such that SMC can make use of the audience it is establishing, across its platforms for cross-promotional opportunities and with the intent of developing a network of interconnected media-focused platforms.

Forward-Looking Statements Disclaimer:

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. In some cases, you can identify forward-looking statements by the following words: “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “ongoing,” “plan,” “potential,” “predict,” “project,” “should,” “will,” “would,” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. Forward-looking statements are not a guarantee of future performance or results and will not necessarily be accurate indications of the times at, or by, which such performance or results will be achieved. Forward-looking statements are based on information available at the time the statements are made and involve known and unknown risks, uncertainty and other factors, including the effect of COVID-19 and the success of the current vaccine distribution, the adverse effect of the Omicron variant, that may cause our results, levels of activity, performance or achievements to be materially different from the information expressed or implied by the forward-looking statements in this press release. This press release should be considered in light of all filings of the Company that are disclosed on the OTC Markets.com website and is not incorporated by reference into such reports.

Disclaimer: PSYC Corporation does not in any way encourage or condone the use, purchase, sale or transfer of any illegal substances, nor do we encourage or condone partaking in any unlawful activities. We support a harm reduction approach for the purpose of education and promoting individual and public safety. If you are choosing to use psychedelic substances, please do so responsibly.

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Psychedelics

Mexican “Shamen” on The Run After Actress Dies In Frog Ceremony

Published

2 weeks ago

December 9, 2024

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An actress in Mexico tragically lost her life after she ingested Amazonian frog venom as a part of a cleansing ritual while at a spiritual retreat. She experienced severe diarrhoea after taking part in the ceremony and was rushed to a hospital, but the doctors failed to save her life.

A shaman at the spiritual retreat where the actress took the Amazonian frog venom that caused her death has fled.

The 33-year-old actress Marcela Alcázar Rodríguez took part in the traditional South American Kambo ritual, which involves drinking water, getting burns on the body, and ingesting frog venom to cleanse the body of toxins, reported the Mirror. However, this ritual is known to have deadly consequences.

How is the Kambo ritual performed?

The participants in the ritual are made to drink more than a litre of water. Small burns are then created on their skin, following which frog mucus is applied on the wounds.

The mucus, which contains venom, increases blood pressure and induces vomiting, reported the outlet. It also causes diarrhoea in some cases. Other symptoms involve fainting, dizziness, swollen lips and face. Usually, the symptoms last for nearly half an hour. However, extended exposure of the venom to the blood stream can cause seizures and also death.

What happened to Marcela Alcázar Rodríguez?

Soon after beginning the ritual, Rodríguez reportedly started throwing up and eventually suffered from severe diarrhoea – these symptoms are often considered the body’s “healing” reactions during the cleansing process. Initially, she refused help but gave in when her friend visited her.

According to the Metro, a shaman at the retreat in Mayocoyani, Durango, told her she couldn’t leave. However, after her condition worsened, the person fled. Reportedly, police are now searching for the shaman.

Tribute to the actress

In a social media post, Durango Film Guild paid tribute to the actress after her untimely demise. They remembered her as “a young woman who worked in various short films, series and movies filmed in Durango.”

The guild added, “She leaves a void in the hearts of the people who knew her working in what she loved: cinema.”

https://www.hindustantimes.com/trending/actress-dies-after-taking-amazonian-frog-venom-during-cleansing-ritual-at-spiritual-retreat-101733371832107.html?ck_subscriber_id=1050193520

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Psychedelics

Dutch police find gnome made of MDMA during drug bust

Published

1 month ago

November 23, 2024

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BBC

Officers in the southern Netherlands have found a garden gnome weighing nearly 2kg (4lb) and made of the drug MDMA.

“Drugs appear in many shapes and sizes, but every now and then we come across special things,” Dongemond Police said in a translated social media post.

The gnome was found among suspected narcotics during a large drug search.

“In itself a strange place to keep your garden gnome,” the force said. “That’s why we decided to test [it] for narcotics”.

“The gnome himself was visibly startled,” police said, referring to the gnome having its hands covering its mouth.

It is not known which area the gnome was recovered in, but the Dongemond Police covers the municipalities of Oosterhout, Geertruidenberg, Drimmelen and Altena.

MDMA – which is an illegal substance in the Netherlands – is a synthetic party drug also known as ecstasy.

As of 2019, the Netherlands was among the world’s leading producers of MDMA.

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Psychedelics

Paper 24 October 2024: Expert recommendations for Germany’s integration of psychedelic-assisted therapy

Published

2 months ago

November 1, 2024

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Psychedelic-assisted therapy (PAT) is a modality of mental health treatment that merges psychotherapeutic interventions with psychedelic states, often facilitated by substances such as lysergic acid diethylamide (LSD), psilocybin, and 3,4-Methylenedioxy-methamphetamine (MDMA). The latter two being in phase III trials. Whereas MDMA is considered an entactogen that enhances self-awareness and emotional connectivity, psilocybin is a naturally occurring psychedelic compound found in certain mushrooms. Recent research suggests that these and other psychedelics, all small molecules, most with benzene or phenyl rings, uniquely work by reopening a “critical period” in the brain, allowing for new learning within social contexts in a process involving changes in brain plasticity and oxytocin signaling [1]. Despite their classification as a Schedule I drugs under the Controlled Substances Act by the Drug Enforcement Agency (DEA) in the United States, their therapeutic potential has been increasingly recognized, with demands from the public to make them available for those with treatment resistant conditions. These among other developments resulted in MDMA being granted Breakthrough Therapy designation by the U.S. Food and Drug Administration (FDA) for the treatment of treatment-resistant PTSD (TR-PTSD) in phase II, (phase III studies were for ‘moderate to severe’ PTSD). Psilocybin (COMP360) and a deuterated psilocybin analogue (CYB003) were granted FDA Breakthrough Therapy designation for treatment resistant depression (TRD) [2,3,4].

Methodologically rigorous clinical research suggests that PAT may offer substantial long-term alleviation of symptoms in patients suffering from psychopathologies such as PTSD, TRD, major depressive disorder (MDD), end of life anxiety, obsessive–compulsive disorder (OCD), substance use disorders (SUD), psychotic conditions, and more [5, 6]. Notably, a single session of substance-assisted therapy has been reported to lead to significant symptom reduction, with some patients achieving remission that can persist for at least twelve months [7]. This enduring effect underscores the potential of psychedelic-assisted therapy in providing therapeutic outcomes that are significantly superior to antidepressant medications such as SSRIs, which often have poor efficacy rates and unwanted side-effects such as agitation, weight gain, sexual performance difficulties, gastrointestinal issues, and other symptoms [1, 8].

In February 2024, Lykos (formerly MAPS PBC) submitted a new drug application (NDA) to the FDA for MDMA (Midomafetamine) capsules in combination with psychotherapy for the treatment of PTSD [9]. Following the submission, a citizen petition was filed, raising concerns about the integrity of the clinical trials. This prompted the FDA to convene an advisory board meeting in June 2024 to review the claims. The petition raised several issues, including alleged bias in the trial design, inadequate sample diversity, insufficient double-blinding, underreporting of adverse events such as sexual misconduct, and confusion regarding the integration of psychotherapy within the study design [10]. Despite the principal view that MDMA trials are sound, and even the FDA’s participation in the creation and oversight of the studies these concerns influenced the FDA’s review process. Subsequently, in August 2024, the FDA issued a final decision rejecting the NDA under the Prescription Drug User Fee Act (PDUFA). It is important to note however that the FDA encouraged ongoing MDMA research and asked for another Phase III trial.

This decision led to additional actions, including the Journal of Psychopharmacology retracting three articles related to the MDMA clinical trials conducted by the MAPS research team and the initiation of an FDA investigation. Lykos has since filed for a reevaluation of their NDA. If approved, MDMA would become the first psychedelic-assisted therapy officially recognized in the United States.

As unexpected as the August 2024 rejection of the application by Lykos for approval of MDMA was for some, the hope based on the phase II studies, remains that either MDMA or psilocybin will within the next two to three years receive a positive evaluation from the FDA although the exact timing remains unknown. Unlike the MDMA trials, where the FDA was initially satisfied with the blinding process prior to the advisory board meeting, Compass’ psilocybin trials were designed to minimize the unblinding caused by psychotropic effects, following the FDA’s advice to their satisfaction until this day.

Lykos and Compass have been the two major companies driving development, and although Lykos has yet to submit a new phase III proposal, Compass continues with their phase III clinical trial. In general enthusiasm in the field for further research continues as there remains a need for novel treatments, and despite the uncertainty, the FDA seems generally favorable toward psychedelic medicine [10].

This paper outlines the current and required infrastructure for the successful integration of PAT, including rescheduling of psychedelic drugs beyond ketamine, accessibility, reimbursement strategies, accreditation of practitioners, ethical considerations and educational requirements. The role of the German government and affiliated agencies is pivotal in shaping this framework, ensuring that the setup not only complies with regulatory standards but also supports the ethical deployment of these therapies.

Moreover, with the European Medicines Agency (EMA) currently deliberating on the integration of psychedelics within the European framework, Germany has a unique opportunity to lead by example, showcasing a meticulous approach to the adoption of psychedelic-assisted therapies and must therefore also prepare to accommodate these innovative treatments [11]. This could serve as a model for other European nations, promoting a harmonized approach to these promising treatments across the continent.

The first half of this paper covers the regulatory environment in Germany, as it is impossible to understand the steps required to make PAT a reality without some in-depth understanding of the country’s unique health care system. The second half of this paper covers the German provision of outpatient mental healthcare and how and where PAT would fit and critically, proposes a training scheme for the education of PAT facilitators.

Historical roots of psychedelics in Germany

Psychedelic research in Germany harkens back to the 1910s and 1920s when the atypical psychedelic MDMA was first synthesized, and pioneering research was being conducted on the properties of mescaline. During this early period, Beringer and colleagues [12] saw in mescaline and similar substances, an opportunity to explore the phenomenology of psychopathology, creating what they described as ‘model psychoses.’ Although problematic in many ways, this stream of research opened up a new dimension of empathy and understanding into the experience of individuals with chronic psychosis [13]. In fact, the research carried out at the University of Heidelberg, culminating in Beringer’s habilitation thesis “Der Meskalinrausch” from 1927, can be considered the first major work in the field of psychedelic psychopharmacology in the West [12]. Another noteworthy event in the history of psychedelic drugs in German-speaking Europe is Albert Hoffman’s accidental discovery of the properties of lysergic acid diethylamide (LSD) on April 19, 1943, which accelerated interest in psychedelic compounds throughout the Western world [14]. In particular, this landmark event led to the widespread experimental use of psychedelics for a diverse range of psychiatric conditions across Europe and North America.

This period of research during the 1950s and 1960s, though short-lived, would later become known as the first wave of psychedelic research [14, 15]. During this brief moment in history, Betty Eisner, a German-educated American, first described the implementation of low-dose LSD in combination with psychotherapy, making a major contribution in the field which still today remains underrecognized [16]. Margot Cutner, a German psychoanalyst who was leading psychedelic research in England after fleeing from the Nazis, provided some of the first insights on the relevance of the role of the facilitator in psychedelic-assisted therapy (PAT) and the now well-known notion of ‘set and setting’ [16]. Following this, Hanscarl Leuner coined the term “psycholytic therapy” at the University of Göttingen underscoring the drug’s therapeutic potential in a sub-threshold dose range [17]. Despite Leuner and colleagues’ extensive research on LSD being among the most comprehensive bodies of work on the topic to date, it has been largely neglected until recently due to never being published in English [18].

A surprising turn of events occurred when in 1961, the United States passed the seemingly politically motivated US Controlled Substances Act, which resulted in an immediate and indefinite suspension of psychedelic research throughout the U.S. Europe was quick to follow suit, and psychedelics became labeled as potentially dangerous and addictive with no accepted medical use [19]. Subsequently, despite early breakthroughs and extensive research, these restrictions ushered in a prohibition era that would last decades, hampering progress and limiting the exploration of psychedelic compounds throughout the Western world. Germany was no exception, and psychedelic treatments now being championed for their therapeutic potential were outlawed.

Economic burden of treating PTSD and depression in Germany

The economic and human costs of PTSD and depression in Germany highlight an urgent need for more effective interventions [20]. Trauma-related healthcare costs range from 524.5 million to 3.3 billion euros annually [21], while depression adds another 1 to 5.2 billion euros [22, 23]. Current pharmaceutical treatments, such as serotonin-reuptake inhibitors (SSRI), offer limited efficacy and fail to fully address the needs of individuals with PTSD, depression, or their comorbidities [24].

A recent study of German insurance claims highlighted both the direct and indirect costs of PTSD (ICD-10-GM F43.1) [20, 21]. PTSD patients typically suffer for about 6 years, with a 50–100% likelihood of comorbid conditions such as major depressive disorder (MDD), panic disorder, and substance use disorder (SUD). Per-patient costs were 43,000 EUR, three times higher than for those without PTSD, driven by increased healthcare utilization, impaired work capacity and reduced quality of life. PTSD also accounts for approximately 200,000 Disability-Adjusted Life Years (DALYs) annually in Germany, a metric that reflects both premature mortality and years lived with disability, quantifying the overall burden of disease [25].

Similarly, depression carries significant economic burdens with indirect costs from labor absenteeism, social benefits, and prevention measures estimated at 10 to 16 billion euros annually, surpassing direct healthcare costs [26, 27]. Depression accounts for approximately 470,000 DALYs in Germany [28], while globally, PTSD contributes an additional 3 million DALYs, underscoring its substantial public health impact.

In short, PTSD and depression remain conditions with a high unmet need. SSRIs, first introduced in 1988 (fluoxetine), are still the primary pharmaceutical treatment for many psychological disorders, despite their limited efficacy and adverse side effects, including symptom exacerbation and suicidal thoughts [29].

Regulatory landscape

The European Medicines Agency (EMA) grants marketing authorization for new medicines across the EU. The sponsor of the medication submits an application for approval to the EMA following phase III trials, and after EMA approval, marketing authorization is granted, which allows the medication to be sold in all European Union member states. Sponsors then must decide which member states they wish to enter, as, even if the Sponsor has marketing authorization, each EU state has its own rules about how health insurers will be reimbursed for new medications. European member states furthermore have country specific processes and infrastructure around the provision of therapeutic services which are an essential part of PAT.

In Germany, the Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM) oversees both clinical trial approval (pre- and post-EMA approval) and the documentation as well as considerations related to safety, efficacy, and quality, and specific labeling requirements tailored to the German context (Fig. 1).

Read full paper

https://bmcmededuc.biomedcentral.com/articles/10.1186/s12909-024-06141-3?utm_medium=email&_hsmi=97789529&utm_content=97789529&utm_source=hs_email

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