Drug Approval

The authorisation granted by a government or regulatory body permitting a company to manufacture, market, or sell a product or service in a specific jurisdiction. Regulatory approvals — including drug approvals (FDA, EMA), financial service licences (FCA, MAS), telecommunications licences, and environmental permits — are recognised as contract-based intangible assets in purchase price allocations under IFRS 3 and ASC 805 when they arise from contractual or legal rights.

A regulatory status granted to drugs developed to treat rare diseases affecting small patient populations, providing incentives such as market exclusivity (7 years in the US, 10 years in the EU), tax credits on clinical trial costs, and reduced regulatory fees. Orphan drug designation significantly enhances the economic value of a pharma intangible asset by creating protected market positions.

A pharmaceutical product that contains the same active ingredient, dosage form, strength, and route of administration as an originator (branded) drug and is demonstrated to be bioequivalent. Generic drugs can be manufactured and marketed after the expiry of the originator's patent protection and regulatory exclusivity periods.

A pharmaceutical product that generates annual revenue exceeding $1 billion, representing a transformational commercial success for its manufacturer. Blockbuster drugs — such as statins, biologics for autoimmune diseases, and oncology treatments — drive the majority of pharmaceutical industry profits and are among the most valuable intangible assets in existence.

The regulatory authorisation granted by the US Food and Drug Administration permitting a medical device to be marketed in the United States, typically through the 510(k) premarket notification pathway for devices that are substantially equivalent to an existing legally marketed device. FDA clearance is distinct from FDA approval (required for higher-risk Class III devices via the Premarket Approval pathway) and represents a significant regulatory intangible asset.

The sequential stages of human testing required before a new drug or medical device can receive regulatory approval. Phase I assesses safety in a small group, Phase II evaluates efficacy and dosing, Phase III confirms effectiveness in large populations, and Phase IV involves post-market surveillance.

The portfolio of drug candidates at various stages of research, development, and regulatory approval within a pharmaceutical or biotechnology company. The pharma pipeline is a critical intangible asset, with each compound's value dependent on its probability of regulatory approval, expected market size, patent protection remaining, and development costs to completion.

A biological medicine that is highly similar to an already approved reference biological product, with no clinically meaningful differences in safety, purity, or potency. Unlike generic small-molecule drugs, biosimilars cannot be exact copies due to the complexity of biological manufacturing processes and require their own clinical trials to demonstrate similarity.