Find the resource for your next decision.

ICH guidelines

Explore harmonised pharmaceutical guidelines in quality, safety, efficacy and multidisciplinary topics.

Publisher

ICH

Resource type

Guideline index

Scope

Quality · safety · efficacy · multidisciplinary

Link checked 2026-09-19

FDA guidance search

Find guidance by product, subject, date and draft or final status at the US authority.

Publisher

US FDA

Resource type

Guidance search

Scope

Draft and final guidance across FDA product areas

Link checked 2026-09-19

EMA scientific guidelines

Browse European guidance on medicine quality, biological products, clinical development and related fields.

Publisher

European Medicines Agency

Resource type

Scientific guideline library

Scope

Human medicines research and development

Last confirmed 2026-09-18; automated recheck was limited by the publisher

WHO pharmaceutical standards

Find WHO resources on pharmaceutical quality assurance and medicines standards.

Publisher

World Health Organization

Resource type

Standards collection

Scope

Pharmaceutical quality assurance and good practices

Link checked 2026-09-19

SFDA laws and regulations

Search the Saudi authority’s collection of laws, regulations and guidance documents.

Publisher

Saudi Food and Drug Authority

Resource type

Laws and regulations index

Scope

Saudi regulatory requirements across regulated product areas

Link checked 2026-09-19

PubMed literature search

Search biomedical citations and follow available links to full-text articles at their publishers or repositories.

Publisher

US National Library of Medicine

Resource type

Literature database

Scope

Biomedical citations, abstracts and available full-text links

Link checked 2026-09-19

DailyMed drug labelling

Find product labelling submitted to FDA, including prescription and nonprescription medicines. The collection is not exhaustive.

Publisher

US National Library of Medicine

Resource type

Medicine label database

Scope

FDA-submitted labelling for prescription and nonprescription products

Link checked 2026-09-19

ClinicalTrials.gov study registry

Open the study registry to look up clinical study records and reported results.

Publisher

US National Institutes of Health

Resource type

Clinical study registry

Scope

Registered studies, protocols and reported results

Link checked 2026-09-19

LactMed: medicines and breastfeeding

Consult referenced information about medicines during breastfeeding, including published evidence and possible alternatives.

Publisher

US National Library of Medicine

Resource type

Referenced clinical database

Scope

Medicines and breastfeeding; evidence and possible alternatives

Link checked 2026-09-19

WHO essential medicines lists

Explore WHO model lists of essential medicines and their original publications.

Publisher

World Health Organization

Resource type

Model list collection

Scope

Adult and paediatric essential medicines lists

Link checked 2026-09-19

EQUATOR research reporting guidelines

Find reporting guidelines and checklists to help describe a study clearly and completely.

Publisher

EQUATOR Network

Resource type

Reporting guideline library

Scope

Study-specific reporting checklists and guidance

Link checked 2026-09-19

MedlinePlus patient medicine information

Find patient-facing information about prescription and nonprescription medicines, herbs and supplements.

Publisher

US National Library of Medicine

Resource type

Patient information library

Scope

Medicines, herbs and supplements for patient education

Link checked 2026-09-19

Current Office website

Open the current website with its existing functions.

The Union’s official website

The Union and its activities.

The Office’s role

The technical reference within the manufacturers’ union.

Vision & mission

Industry development, capability building and harmonisation.

Founding board

Board members and their responsibilities.

Trust Centre

Sources, corrections and data handling.

Governance & continuity

Committee responsibilities and published update schedules.

Fields of expertise

Regulatory, industrial and academic disciplines.

Industry & authority support

Product lifecycle support and inspector capability building.

Global engagement

Published contributions to regulatory consultations.

Arab regulatory atlas

National medicines authorities across Arab markets.

The Morning Brief

Arab and international updates and enforcement activity.

The Regulatory Report

Dated editions and citable datasets.

What’s new

New and updated content and tools.

Change Radar

Developments from Arab medicines authorities.

Regulatory Index

Arab and international updates with their references.

Reference Product Register

Resources for comparator product selection.

API & Excipient Data Bank

Raw materials, origins and supply routes.

Enforcement Watch

Inspection findings, warnings and non-compliance actions.

The Boardroom

Executive briefs and business risk exposure.

Decision Engine

Compare options, assumptions and uncertainty.

CEO Academy

Lessons, decision exercises and a conference radar.

Tender & Localisation Suite

Work with bid economics and localisation requirements.

Decision Record & Ledger

Record decisions, reasoning and dissent.

Proposal Interrogation Bench

Review questions grounded in a proposal’s numbers.

Margin-at-Risk Console

Explore how currency changes affect margins.

First-Filer Window Radar

Exclusivity dates and subsequent filing opportunities.

All studios

An entry point to the specialist pharmaceutical studios.

Technical Solutions Bank

Connect a practical problem to a tool or reference.

Supply Resilience Studio

Sourcing, inventory, shipping routes and risk.

Stability & Climatic-Zone Studio

Stability studies, temperature and humidity.

Medical Device Regulatory Studio

Device classification and registration requirements.

Data Integrity Studio

Data governance, audit trails and validation.

Counterfeit & Falsified Products Studio

Traceability, warning signs and response pathways.

Qualified Person Diploma Studio

Published courses, films and assessments.

QP Live · 45 topics / 150 hours

45 English live lectures, worked practicals and facilitator guides across a complete 150-hour core.

QC & Laboratory Studio

Result investigations and analytical method validation.

Biosimilar & Biotechnology Studio

Analytical similarity and development evidence.

Bioequivalence & Biowaiver Studio

Study design and biowaiver criteria.

Value-Added & Combination Studio

Regulatory routes and supporting evidence.

Registration Navigator

Registration requirements across Arab markets.

GMP Readiness Self-Check

Identify gaps and improvement priorities.

Halal Pharmaceutical Compliance

Excipients, segregation and compliance readiness.

Supply Watch

Follow disruption and shortage signals.

Renewal & Variation Tracker

Organise deadlines for registered products.

Landmark Technical Assets

The Arab guideline, registers and inspection dashboard.

Marketing Command Centre

Resources for pharmaceutical marketing and planning.

Certificate evidence checker

Review the evidence inside a Certificate of Analysis or Certificate of Conformity before relying on its title.

Medicines inspection at air and land borders

A practical consignment review sheet for inspectors: documents, storage, temperature evidence and unresolved concerns.

Regulatory response planner

Turn each authority question into an action, an evidence reference and an accountable review.

GMP Inspection Platform

The platform’s scope and functions.

Assurance Centre

Documented records and review outputs.

Inspection Field Kit

Report formats and documentation tools.

Inside the Inspection Dashboard

Explore the scope of assessment items.

Open the GMP Dashboard

Launch the current dashboard with its existing access rules.

Contamination Control Strategy

The system and its approach to evaluating controls.

Contamination Control Limit Tables

Reference tables and their applications.

Constants That Need Care

Points the Office explains to help avoid misapplication.

Control Assessment Method

Understand the assessment method and its limits.

Contamination Control Elements

Explore the elements in the Office’s clause commentary.

Contamination Control Tour

A visual introduction to the dashboard.

Open the CCS Dashboard

Launch the current dashboard with its existing access rules.

Research Hub

Sources and datasets for research.

Research & Academia

Cite datasets and use resources in teaching.

Training & Workshops

Published programmes, dates and registration.

Knowledge & Newsletter

Series archives, reports and scientific publications.

Live from the Office

Updates from the community and the Office.

Expert Forums

Discussion and knowledge exchange among specialists.

Apply for Membership

Current requirements and applications to the Scientific Committee.

Cooperation & Partnerships

Work with authorities, industry and universities.

Expert Workspace

The current workspace with existing expert accounts.

Contact the Office

Official contact channels.

Arab Pharmaceutical Manufacturers Register

Coverage, manufacturing capabilities and verification status.

Open Dataset Pages

An entry point to the reference dataset pages.

Reference Product Dataset

A stable reference page for researchers.

Solutions Bank Dataset

The technical solutions dataset page.

API & Excipient Dataset

The dataset and citation page.

Research Source Dataset

The Research Hub’s source page.

Public Consultation Notice

The Office’s published Arab guideline consultation notice.

Arab GMP Guideline — editable draft

Published draft v0.96 in document format.

Arab GMP Guideline — reading edition

Published draft v0.96 in PDF format.

Guideline Comment Form

The original form from the consultation pack.

Inspector Baseer

The film, exercise and assessment programme.

Terms of Use

Terms published on the current website.

Privacy Policy

The current website’s data-handling policy.