Regulatory Justification (drug development)

Provide assistance on regulatory requirements and regulatory justifications
(e.g. the regulatory requirements and regulatory justifications for a particular clinical trial design or formulation bridging/dissolution strategy)

RS Expert Database

An expert database is empowered with knowledge and expertise to support applications, which access large shared databases (shown below).

Expert Database Development >>

Expert Interpretation

Seek regulatory interpretations from the experts (in different disciplines) with significant real-case experience on FDA, EU and CFDA regulatory affairs.

Regulatory Assistance (Expert Team) >>

Large Databases

FDA Guidance Documents

Guidance documents represent the Agency's current thinking on a particular subject. An alternative approach may be used if such approach satisfies the requirements of the applicable statute, regulations, or both.

Guidance database collection >>

Drugs@FDA: FDA-Approved Drugs

For prescription brand-name drugs, Drugs@FDA includes the most recent labeling approved by the FDA, regulatory information, and FDA staff reviews that evaluate the safety and effectiveness of the drug.

Review database collection >>

Clinical Trials (US)

Since January 2017, it expands the scope of the results database by requiring the submission of results information for trials of unapproved products and additional information for summarizing trial results.

Trial (US) database collection >>

EMA 指南 (Scientific Guidelines)

Guidelines reflect a harmonised approach of the EU Member States and the European Medicines Agency (EMA) on how to interpret and apply the requirements for the demonstration of quality, safety and efficacy.

Guideline database collection >>

Assessment Reports (CHMP)

EMA publishes information on medicines at various stages of their lifecycles, from early development through initial evaluation to post-authorisation changes, safety reviews and withdrawals of authorisation.

Assessment database collection >>

Clinical Trials (EU)

The EU Clinical Trials Register contains information on interventional clinical trials on medicines conducted in the European Union (EU), or the European Economic Area (EEA) which started after 1 May 2004.

Trial (EU) database collection >>

FDA Online Label Repository

The National Library of Medicine’s download labels site (DailyMed database) contains 135419 drug listings (41990 prescriptions), as of January 2021, submitted to the Food and Drug Administration (FDA) by companies.

Drug Label database collection >>

Library of Medicine Data

TOXLINE: A database for biochemical, pharmacological, physiological, and toxicological effects of drugs and other chemicals (TOXLINE has recently been integrated into other NLM databases).

Toxicology database collection >>

US Patent Database

USPTO is continuing to release APIs so that anyone with the most basic programming experience will be able to explore our data according to their own interests, curiosity, and business needs.

USPTO database collection >>

Small Molecules and Bioactivity

Chemical Entities of Biological Interest (ChEBI) is a freely available dictionary of molecular entities focused on ‘small’ chemical compounds. Each data item is fully traceable and referenced to the original source.

ChEBI database collection >>

National Library of Medicine

PubChem is the world's largest collection of freely accessible chemical information: chemical and physical properties, biological activities, safety and toxicity information, patents, literature citations and more.

PubChem database collection >>

Chemistry (Crowdsourced Annotation)

ChemSpider is a free chemical structure database providing fast access to over 100 million structures, properties, and associated information (by integrating and linking compounds from high-quality data sources).

ChemSpider database collection >>