Authoritative pharmaceutical reference directory

Authority does not mean universal applicability

Official sources are strongest when used for the question and jurisdiction they actually address. An FDA database can establish information about an FDA-regulated product; it does not establish Lao registration. WHO guidance can provide internationally used technical context; it does not certify a company. ICH guidance can describe a harmonised technical framework; it does not prove that a particular product or site complies with it.

For every source, record the issuer, page or document title, date or version where available, the jurisdiction or programme, and the exact fact you are using it to support. Keep that note beside the claim rather than treating a long bibliography as proof of everything on the page.

Product identity, approval and interchangeability

• FDA Drugs@FDA and Orange Book: useful for US-approved product identity, application information and FDA therapeutic-equivalence evaluations where provided.
• EMA product information: useful for authorised EU product information within the relevant procedure and scope.
• WHO multisource-product guidance: explains evidence principles for establishing interchangeability; it is not a list declaring unrelated products interchangeable.

Use these sources to understand the regulatory concept and the specific products they cover. Do not transfer an approval, indication or equivalence conclusion to a development record with a similar ingredient name.

Quality systems, GMP and laboratory evidence

• WHO GMP and sterile-GMP guidance: technical expectations for manufacturing quality systems and sterile operations.
• ICH quality guidelines: harmonised technical guidance covering stability, analytical validation, pharmaceutical development, risk management and quality systems.
• WHO quality-control laboratory guidance and model certificate of analysis: laboratory practice and batch-test reporting concepts.

These references describe expectations and document structures. They do not establish that the Boten project has passed an inspection, completed qualification or released a batch.

Pharmacopoeias and reference standards

The International Pharmacopoeia, national or regional pharmacopoeias and their reference standards support compendial testing and quality specifications within their stated framework. The applicable standard must be identified for the product and jurisdiction. A monograph is not a marketing authorisation and a reference standard is not a commercial product approval.

WHO publishes an index of world pharmacopoeias and information on International Chemical Reference Substances. Use the current issuing authority and monograph rather than assuming two compendia are interchangeable.

Safety, quality defects and falsified products

WHO pharmacovigilance and substandard/falsified-product resources provide global context. National authorities operate their own reporting and alert systems. FDA MedWatch is a US reporting system. Choose the route that corresponds to the country, product and event rather than sending sensitive information indiscriminately to every available mailbox.

The Luang Pharma safety page currently publishes a general company email route and explains its limits. It is not described as a continuously monitored pharmacovigilance system.

Devices and diagnostics

WHO and national device regulators publish classification, intended-use and performance frameworks. Regulatory status is model- and jurisdiction-specific. Search by exact manufacturer, model, intended use and relevant identifier when available; a generic device type is not enough to establish approval or compatibility.

A reproducible source note

1. Write the exact question first.
2. Choose the competent authority or technical source for that question.
3. Record the exact product, site, jurisdiction or technical scope covered.
4. Record the source title, URL and date/version where available.
5. State explicitly what the source does not establish.

The downloadable reference-directory CSV on the Resources page provides a machine-readable list of the official sources used by this website. It is a navigation aid, not a substitute for checking the live issuing source.