Pharmaceutical partnerships Proposed collaboration model FDA guidance checked October 22, 2026

In botanical drug research, EUTECNIQ would supply characterized material, methods and formulations; a qualified sponsor would run the regulated studies

For drug developers, investigators and contract organizations studying botanical candidates: FDA's botanical IND and approval record, the rules a program meets, and what EUTECNIQ would and would not contribute.

Status. EUTECNIQ is in formation. It has no drug programs, no GLP or GCP capability and no drug manufacturing, and it does not plan to manufacture drugs. Everything EUTECNIQ would contribute on this page is a proposal.

739botanical INDs received by FDA from March 1984 to December 2020 (Park et al. 2025)

4botanical drugs approved: three NDAs and one BLA (FDA, September 2026)

69% vs 58%of oncologic and other botanical INDs safe to proceed at 30 days

9CFR parts frame a botanical drug program from IND to NDA (eCFR)

The journey

Four kinds of partner need well-characterized botanical material before regulated studies begin

Choose a partner to follow its path from the rules its program meets to the research documents it would receiveProposed service flow

Rules link to eCFR; a sponsor and its qualified contractors carry them out. EUTECNIQ's services would be research work outside GLP, and its documents would be labeled for research use; EUTECNIQ has no laboratory yet.

Text version: partners, rules, services and documents

Partners

Drug developers Need a candidate's composition, variability and process understood before committing to IND-enabling work.
Academic investigators Need research material that can be described, repeated and compared.
Contract organizations CROs and drug manufacturers needing a botanical characterization and process-development partner.
Supplement companies Ask whether a drug pathway exists for an ingredient they already sell.

Rules the partner's program meets

21 CFR 312 The sponsor's IND, including chemistry and manufacturing information.
21 CFR 58 GLP for nonclinical studies that support an IND.
21 CFR 50 and 56 Informed consent and IRB review in clinical investigations.
21 CFR 210 and 211 Drug CGMP for clinical supply and commercial product.
21 CFR 314 New drug applications; adequate and well-controlled studies.

Research services (proposed; outside GLP)

Sourcing and authentication Species, plant part, vouchers, supplier records.
Characterization Fingerprints, marker assays, batch comparison.
Process development Research-scale extraction and fractionation with mass balance.
Research formulations For in vitro and animal studies run by partners.
Exploratory screening Hypothesis-generating, never efficacy evidence.
Interaction questions In vitro screens that flag possible drug interactions for partners to study properly.

What the partner would receive (for research use)

The problem

A botanical drug program depends on proving that every batch has the same effect

A botanical mixture cannot be controlled by one assay, so FDA relies on the totality of the evidence.

Four kinds of evidence together show batch-to-batch therapeutic consistencyFinal guidance

FDA, Botanical Drug Development: Guidance for Industry, Revision 1 (December 2016), final; docket FDA-2000-D-0103.

Text version: why characterization comes first

Work done with poorly characterized material cannot be repeated or built on. Characterization, sourcing and process knowledge are therefore the first things a partner needs, and they are where EUTECNIQ proposes to contribute.

FDA, "Botanical Drug Development: Guidance for Industry," Revision 1 (December 2016), final; docket FDA-2000-D-0103.

Division of work

EUTECNIQ's proposed role ends where GLP, GCP and drug cGMP begin

Stages 1 to 4 would be EUTECNIQ research; stages 5 to 7 are regulated work led by a sponsor.

EUTECNIQ's proposed research sits before the line where GLP, GCP and drug cGMP beginProposed role Governing rules

eCFR, 21 CFR Parts 50, 56, 58, 210, 211, 312 and 42 CFR Part 11, current to October 21, 2026; FDA, E6(R3) Good Clinical Practice, final guidance (docket FDA-2023-D-1955).

Text version: the seven stages and who does the regulated work

Candidate and questionIndication hypothesis and material needs, set jointlyJoint
Material characterizationAuthentication, fingerprints, batch comparisonEUTECNIQ
Process and methodsExtraction, fractionation, analytical methodsEUTECNIQ
Research formulationVehicles for in vitro and animal researchEUTECNIQ
GLP nonclinical studiesIND-enabling safety studiesPartner
IND and clinical trialsSponsor, sites, IRBsSponsor
Clinical supply and applicationDrug cGMP manufacture; NDA or BLASponsor and CDMO

Regulated activities in drug development, who would perform them and the governing rule.
Regulated activity	Who would do it	Governing rule
Investigational new drug application and FDA meetings	The drug sponsor	21 CFR Part 312 Final rule
Nonclinical safety studies supporting an IND or marketing application	A contract research organization operating under GLP	21 CFR Part 58 Final rule
Clinical trials	The sponsor, clinical sites and institutional review boards	21 CFR Parts 50, 56 and 312 Final rule; FDA, "E6(R3) Good Clinical Practice" (September 2025) Final guidance
Trial registration	The responsible party, usually the sponsor, for applicable clinical trials	42 CFR Part 11 Final rule
Clinical and commercial drug manufacture	A contract manufacturer operating under drug cGMP	21 CFR Parts 210 and 211 Final rule
Marketing application	The sponsor	FD&C Act § 505 (NDA) or a biologics license (BLA)

eCFR, 21 CFR Parts 50, 56, 58, 210, 211, 312 and 42 CFR Part 11, current to October 21, 2026; FDA, "E6(R3) Good Clinical Practice (GCP)," final guidance, docket FDA-2023-D-1955. See the toxicology and clinical research pages.

Five things EUTECNIQ would not do, and four distinctions

Stating the limits up front protects partners and keeps the regulatory record clean.

Manufacture drugs or clinical-trial material.Supplement cGMP under Part 111 is not drug cGMP under Parts 210/211.
Sponsor or self-fund drug clinical trials.Trials would be run by a sponsor under an IND.
Run GLP or GCP studies in house.Not unless and until EUTECNIQ is qualified to do so; until then they are partner-led.
Describe research material as fit for human dosing in a drug trial.Clinical supply comes from a drug cGMP manufacturer.
Make disease claims for its supplement, food or cosmetic ingredients.Drug research on a botanical does not change how a consumer product may be labeled.

Activity in a cell or animal study≠Efficacy in patients
Structure/function study of a supplement≠Evidence of drug effectiveness
Research-grade material≠Clinical-trial supply
ISO/IEC 17025 accreditation≠GLP compliance

What EUTECNIQ would contribute

Six research services, all upstream of regulated studies

Six proposed research services, each reported as research work outside GLPProposal

EUTECNIQ proposal. Methods intended for drug release testing would be validated where drug cGMP applies. More on the translational research page.

The six services in detail

Sourcing and authentication Proposal

Species and plant-part confirmation, voucher specimens, supplier qualification and raw-material records that later support FDA's raw-material control expectations.

Characterization Proposal

Chemical fingerprints, marker assays and batch-to-batch comparison. Methods intended for drug release testing would be validated where drug cGMP applies.

Process development Proposal

Extraction and fractionation at research scale, with mass balance and the process knowledge a drug manufacturer needs for transfer.

Research formulations Proposal

Solutions, suspensions and emulsions for in vitro and animal research run by partners, with composition and stability data.

Exploratory screening Proposal

Physicochemical profiling, dissolution and computational screening to prioritize fractions. Hypothesis-generating, never efficacy evidence.

Interaction questions Proposal

Exploratory in vitro screens, such as enzyme inhibition, to flag possible natural product–drug interactions for partners to study properly.

The record

FDA received 739 botanical INDs from 1984 to 2020 and has approved four botanical drugs

Oncologic botanical INDs were more often safe to proceed at 30 days (69% vs 58%); the four approvals came in 2006, 2012, 2022 and 2023Published FDA data

INDs and approvals are separate counts over different periods; the chart does not imply that any IND led to an approval.INDs: Park JK, Lee D, Rui L, Gao X, Furness MS, Wu C (FDA authors), Ther Innov Regul Sci 2025;59:1129–1137 (CDER botanical IND database, March 1984 to December 2020; 254 oncologic, 485 non-oncologic). Approvals: FDA, Botanical Drug Products (September 3, 2026); dates from Drugs@FDA via openFDA, read October 24, 2026.

Data table: INDs and approvals

Botanical INDs received by FDA, March 1984 to December 2020 (Park et al. 2025)
Group	INDs	Still active at analysis	Safe to proceed at 30 days
Oncologic, phase 1 proposed	137	46	69%
Oncologic, phase 2 or 3 proposed	117	36 (3 in phase 3)	69%
Non-oncologic	485	not reported in the abstract	58%

Botanical products approved as prescription drugs (FDA; Drugs@FDA)
Product	Application	Approved	Botanical source, from the labeling
Veregen (sinecatechins)	NDA 021902	October 31, 2006	Partially purified fraction of the water extract of green tea leaves (Camellia sinensis)
Mytesi (crofelemer)	NDA 202292	December 31, 2012	Derived from the red latex of Croton lechleri
NexoBrid (anacaulase-bcdb)	BLA 761192	December 28, 2022	Proteolytic enzymes extracted from the stems of pineapple plants (Ananas comosus)
Filsuvez (birch triterpenes)	NDA 215064	December 18, 2023	Dry extract, refined, from birch bark (Betula pendula, Betula pubescens)

Nine CFR parts frame a botanical drug program from IND to NDA; the NDA and IND rules are the longesteCFR counts

Area is the number of sections in eCFR, a measure of length, not of importance; "*" marks parts that apply only in some programs. Select a part to open it in eCFR.Section counts from the eCFR API, titles 21 and 42 up to date as of October 21, 2026; selection of parts by EUTECNIQ from FDA's botanical drug guidance (December 2016). These are the sponsor's obligations; see the CFR atlas for consumer-product rules.

Data table: the nine parts

CFR parts for a botanical drug program: A botanical drug program from IND to NDA (eCFR section counts)
Rule set	What it covers	Agency group	eCFR sections	Level
21 CFR Part 312	Investigational New Drug Application. Investigational new drug applications: what a sponsor files before testing a drug in people.	FDA · 21 CFR	60	Applies
21 CFR Part 50	Protection of Human Subjects. Informed consent of human subjects in FDA-regulated clinical investigations.	FDA · 21 CFR	15	Applies
21 CFR Part 56	Institutional Review Boards. Institutional review boards that review and approve clinical investigations.	FDA · 21 CFR	20	Applies
21 CFR Part 58	Good Laboratory Practice for Nonclinical Laboratory Studies. Good laboratory practice for nonclinical studies that support INDs and marketing applications.	FDA · 21 CFR	36	Applies
21 CFR Part 314	Applications for FDA Approval to Market a New Drug. New drug applications; § 314.126 defines adequate and well-controlled studies.	FDA · 21 CFR	68	Applies
21 CFR Part 211	Current Good Manufacturing Practice for Finished Pharmaceuticals. Current good manufacturing practice for finished pharmaceuticals.	FDA · 21 CFR	60	Applies
21 CFR Part 210	Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs; General. Drug CGMP: scope, applicability and definitions.	FDA · 21 CFR	3	Applies
21 CFR Part 320	Bioavailability and Bioequivalence Requirements. Bioavailability and bioequivalence requirements for drug products.	FDA · 21 CFR	19	Check
42 CFR Part 11	Clinical Trials Registration and Results Information Submission. Registration and results reporting for applicable clinical trials on ClinicalTrials.gov.	NIH · 42 CFR	20	Check
Total	9 rule sets; 7 apply, the rest apply only in the circumstances they name		301	262 in rules that apply

FDA's framework

FDA's botanical drug guidance sets four ideas a partner plans around

Revision 1, December 2016, replaced the June 2004 guidance. Its recommendations are not binding.

One botanical, two legal paths, and the bridge FDA's guidance draws between themFinal guidance FDA statement

FDA, Botanical Drug Development (December 2016, Revision 1), docket FDA-2000-D-0103; FDA, What Is a Botanical Drug? (undated page, read October 22, 2026).

Text version of the guidance's four ideas and the approvals

Scope Final guidance: Botanicals "include plant materials, algae, macroscopic fungi." Highly purified or chemically modified substances, even of natural origin, fall outside the botanical approach.
Therapeutic consistency Final guidance: Batch-to-batch consistency is shown by the totality of the evidence: raw-material control, chemistry and manufacturing controls, biological assays and clinical data.
Prior human use Final guidance: For a botanical lawfully marketed in the United States as a dietary supplement, initial clinical studies may proceed without further nonclinical testing when the prior use is similar to the proposed use, and early chemistry and manufacturing information can be less detailed.
OTC route Final guidance: A botanical marketed for a material time and extent for a specific OTC indication may be eligible for the OTC monograph system; FDA may also approve an OTC botanical through a new drug application.
Approvals to date FDA statement: FDA states that four botanical products have been approved as prescription drugs: three under new drug applications (sinecatechins, crofelemer and birch triterpenes) and one under a biologics license (anacaulase-bcdb). FDA, "What Is a Botanical Drug?" (undated page, read October 22, 2026).

FDA, "Botanical Drug Development: Guidance for Industry" (December 2016, Revision 1), docket FDA-2000-D-0103.

Evidence levels

Five levels of evidence, and what each contributes to a drug program

Only adequate and well-controlled clinical investigations establish effectivenessRoles per regulation and guidance

21 CFR 58.1 and 58.3; 21 CFR 314.126(a); FDA, Botanical Drug Development (December 2016).

Text version of the evidence levels

Evidence levels with what each shows, what it cannot show, and its role in botanical drug development.
Level	What it shows	What it cannot show	Role in a drug program
1 Identity and composition	The material is what it is said to be, at a defined composition.	Safety or effect.	The base of chemistry, manufacturing and controls and of therapeutic consistency.
2 Safety	The material is safe enough for the planned exposure.	Effect.	Nonclinical studies supporting an IND fall under GLP; prior human use may reduce what is needed to start.
3 Biological activity	A mechanism or signal in cells or animals.	Effect in patients.	Supports the rationale and dose selection.
4 Exposure	Pharmacokinetics of marker or active constituents.	Effect.	Clinical pharmacology for dose and interaction assessment.
5 Human outcome	Effect in patients under controlled conditions.	Effects outside the studied population and indication.	Adequate and well-controlled investigations are the primary basis for "substantial evidence" of effectiveness.

Studying a botanical candidate?

Describe the material, the research question and the stage of your program. The first reply would set out what characterization and process work would make your results reproducible.

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