The MLR Review Process: A Practical Guide for Regulatory Affairs Teams

Every piece of promotional material that reaches a healthcare professional or patient has passed through — or should have passed through — a Medical, Legal, and Regulatory (MLR) review. Despite its central role in ensuring compliant communication, MLR review remains one of the most poorly defined processes in many pharmaceutical and medical device companies. Teams know it matters, but the workflow is often ad hoc, the documentation incomplete, and the bottlenecks chronic. This guide sets out a practical framework for getting MLR right.

What MLR Review Actually Involves

MLR review is the formal process by which promotional and medical materials are assessed for scientific accuracy, legal compliance, and regulatory conformity before they are approved for use. This covers a wide spectrum: detail aids, patient information leaflets, social media posts, conference materials, website content, speaker slide decks, and any other material that makes claims about a product.

The review is not a single checkpoint. It is a structured series of assessments, each performed by a distinct discipline, culminating in a documented approval decision. The goal is to ensure that every claim is truthful, not misleading, substantiated by evidence, consistent with the approved prescribing information, and compliant with applicable advertising regulations — in South Africa, this means alignment with the Medicines and Related Substances Act (Act 101 of 1965), SAHPRA guidelines, and the Marketing Code administered by the Marketing Code Authority (MCA).

Who Should Be in the Room

The acronym names the three core reviewers, but the practical composition of the review committee matters more than the labels.

Medical reviewers — typically a medical advisor or medical director — assess clinical accuracy. They verify that claims are supported by the referenced data, that the data is presented without distortion, and that the overall impression of the material is consistent with the product's benefit–risk profile.

Legal reviewers examine intellectual property considerations, comparative claims, potential defamation risks, and compliance with advertising law. In South Africa, they should also be alert to Consumer Protection Act implications when materials are directed at patients rather than healthcare professionals.

Regulatory reviewers confirm that the material aligns with the approved package insert, that mandatory elements (such as scheduling status, proprietary name, and SAHPRA registration number) are present and correct, and that the material conforms to applicable SAHPRA guidance and MCA requirements.

Beyond these three, it is often necessary to include a brand or marketing representative who can speak to the intended use and audience, and a compliance officer for materials that involve interactions with healthcare professionals, such as sponsorships or speaker programmes.

Structuring the Review File

A well-structured submission file eliminates the single largest source of delay: reviewers asking for information that should have been provided upfront. Every material submitted for MLR review should be accompanied by a standardised briefing document containing the target audience, intended channels and markets, the approved prescribing information version used, a claims and references matrix linking each claim to its supporting data source, and any prior approval history if the material is a revision.

The claims and references matrix deserves particular emphasis. This document maps every factual or promotional claim in the material to a specific reference — a clinical trial publication, the approved PI, real-world evidence, or other substantiated source. Without it, medical and regulatory reviewers spend their time hunting for context rather than evaluating accuracy.

Common Bottlenecks and How to Avoid Them

Late-stage content changes. Marketing teams frequently submit near-final materials and then request significant copy changes after the first review round. This resets the review clock. The fix is disciplinary: content should be substantially final before entering MLR, with only minor refinements expected after review.

Ambiguous approval criteria. Without clear, written standards for what constitutes an acceptable claim or a compliant layout, reviewers apply their own judgement inconsistently. Developing a house style guide and a claims policy — specific to your therapeutic areas — gives reviewers a shared benchmark.

Sequential rather than parallel review. Routing materials from medical to legal to regulatory in sequence triples the calendar time. Where possible, all three reviewers should assess the material simultaneously, with a single consolidation meeting to resolve conflicting feedback.

Poor version control. Nothing derails an MLR process faster than reviewers commenting on different versions of the same document. A single document management system with enforced version numbering is not optional — it is foundational.

No escalation pathway. Disagreements between reviewers are inevitable, particularly on comparative claims or off-label adjacency. Define in advance who has the authority to make a final call, and document the rationale when a disputed decision is made.

Documentation and Audit Readiness

Every MLR decision — approval, rejection, or approval with conditions — must be documented and retained. This is not bureaucratic excess; it is your evidence of due diligence in the event of a regulatory query or MCA complaint. Retain the final approved material, the claims and references matrix, all reviewer comments, the approval decision with date and signatories, and records of any post-approval amendments.

Avidara's Document Review service helps regulatory affairs teams identify gaps in their promotional and medical materials before they enter MLR, reducing review cycles and strengthening compliance documentation. If your MLR process needs sharper structure or your materials need a pre-submission regulatory check, book a review.