Healthcare & Pharma: Trusted data to innovate and stay compliant
Structure your healthcare and pharma data to innovate faster and stay compliant with regulations.
The healthcare, pharmacy and para-pharmacy sector operates in a complex, demanding regulatory environment where data reliability is essential.
Product information, patient leaflets, clinical, regulatory and logistics data: their structure and distribution must meet strict standards to ensure compliance, traceability and patient safety.
As a result, centralised and well-governed data management becomes a strategic lever to accelerate innovation, reduce time-to-market and strengthen operational performance across the sector.
A sector shaped by strict rules and an international reach
Give your organisation the means to manage master data in a consolidated, flexible and comprehensive way. MaPS System MDM redefines the standards for data management solutions, combining transparency with scalability.
In 2023, the turnover of France’s regulated pharmaceutical market reached €26.2 billion, placing the country 5th worldwide. The sector is tightly governed by mechanisms such as the “safeguard clause”, which caps growth by requiring pharmaceutical companies to make a financial contribution once expenditure exceeds a defined threshold. At European level, France stands out for stricter regulation than in other countries, where the framework is generally more supportive of industry growth.
In France, advertising for medicines is subject to prior authorisation from the ANSM (the French medicines regulator) via a specific approval (“visa”): a GP visa for the general public and a PM visa for healthcare professionals. Only certain non-prescription medicines may be advertised to the public, and only under strict conditions.
Each promotional message must be consistent with the marketing authorisation (AMM), factual and unambiguous. This framework is designed to ensure information is reliable, tightly regulated and aligned with public health priorities.
Access to health information has grown significantly online. Patients and consumers now have many sources—specialist websites, institutional platforms and social media—which can foster greater autonomy, but also create risks: unverified information, misinformation, and confusion between scientific communication and promotional messaging.
In this context, manufacturers must guarantee the reliability, consistency and compliance of the information they publish. Rigorous product information management is essential to maintain patient and consumer trust and to meet the regulatory requirements of each country where products are marketed.
In France, online sales of medicines remain limited: only 838 pharmacies are currently authorised to do so, within a highly regulated framework (over-the-counter medicines only, via a website linked to a registered community pharmacy, with strict restrictions on promotion and advertising). By contrast, countries such as Germany and the Netherlands operate under more flexible rules for online supply, which has supported the growth of online pharmacies.
However, the digitalisation of the healthcare sector goes beyond medicines: skincare and personal care products, parapharmacy items, medical devices, food supplements, and more. These categories are not subject to the same restrictions and represent a major growth lever for industry players. To meet regulatory requirements, ensure consistent omnichannel delivery and speed up time-to-market for these products, robust data structuring and governance become critical priorities.
Nearly 50% of the French pharmaceutical industry’s turnover is generated through exports, reflecting its global reach. This international dimension brings stringent requirements: adapting to local regulations, ensuring customs compliance, and managing multilingual patient information leaflets, packaging and product information.
Whether you are launching medicines, medical devices, food supplements or parapharmacy products, bringing products to market in the healthcare and pharma sector follows strict processes that differ by category. Medicines and medical devices must go through demanding regulatory pathways (clinical trials, benefit–risk assessment, submission of dossiers to the ANSM, the EMA or the FDA, obtaining marketing authorisation (AMM) or CE marking, etc.).
For other products—skincare, cosmetics and health nutrition—specific requirements also apply, including labelling rules, tightly regulated claims, traceability obligations and compliance with relevant frameworks (MDR, INCI, DPP, etc.).
In all cases, the quality, completeness and traceability of regulatory data are essential to ensure compliance, secure product launches and meet the expectations of both authorities and consumers.
Demanding business challenges specific to the healthcare & pharma sector
Ensure your product data remains compliant with the applicable regulations in each target country.
- Monitor national and international requirements (ANSM, EMA, FDA, MDR, DPP, etc.)
- Frequently update regulatory data
- Manage mandatory product information: labelling, patient information leaflets, packaging, etc.
- Maintain compliant archiving and full change traceability
- Carry out regular audits to confirm adherence to legal obligations
Guarantee product information that is reliable, consistent and easy to access.
- Centralise data from multiple sources (R&D, Quality, Regulatory Affairs, Marketing, etc.)
- Ensure rigorous structuring, validation and full traceability of product information
- Reduce data entry and versioning errors (product sheets, leaflets, ingredients/components, contraindications, etc.)
Optimise data flows and protect sensitive information throughout the lifecycle.
- Integrate systems (ERP, PLM, CRM, pharmacy management systems, etc.)
- Secure sensitive data flows (clinical, product, consumer, pharmacy and—where applicable—distribution network data, etc.)
- Enforce robust access governance and role-based permissions
Manage the production and updating of thousands of product assets efficiently.
- Increasing complexity in product data management (images, technical information, translations, etc.)
- Need to coordinate multiple projects simultaneously across different markets
- High content volumes, varying significantly by geographical region
Adapt content and product strategy to the regulatory and cultural specifics of each market.
- Tailor product pages, leaflets and marketing content to local requirements
- Manage translation, formatting and local certifications, etc.
- Coordinate with subsidiaries or distributors across multiple countries
Bring products to market faster without compromising quality or compliance.
- Smooth coordination across teams (Regulatory Affairs, Marketing, Logistics, Sales, etc.)
- Reduce the time between product approval and market launch
- Automate data flows to minimise manual work
Deliver consistent, contextualised product information across every channel.
- Publish product data across multiple channels (eCommerce websites, partner portals, ERP, point-of-sale materials, brochures, etc.)
- Tailor messaging to each audience (B2B, pharmacists, end consumers, etc.)
- Ensure communications comply with channel-specific and regulatory constraints
Balance brand consistency with local personalisation.
- Maintain a consistent, unified brand image at national level
- Harmonise messages, visuals and collateral across the entire network
- Account for local specifics to enable appropriate localisation
- Strike the right balance between centralised content and local flexibility
- Put governance in place to control usage rights, versions and approvals
Be able to act quickly in the event of an incident or non-compliance.
- Update information rapidly across all channels
- Structured escalation process for withdrawals, changes or urgent communications
- Reliable audit trails and regulatory evidence
- Consolidated view of activity across different pharmacy management systems
Prenez le contrôle de vos données produit & de référence
Dans un secteur où la réglementation varie fortement selon les catégories de produits – médicament, dispositif médical, complément alimentaire, cosmétique, soin, hygiène – une gouvernance rigoureuse des données est essentielle. Elle permet de garantir la conformité, d’accélérer les lancements, et d’assurer une diffusion cohérente et multicanale de l’information.
Découvrez les données stratégiques à centraliser et maîtriser dans le secteur santé & pharma :
Identification & classification
- Nom commercial, dénomination de vente, description produit
- Références internes, codes fabricant, GTIN, code CIP (le cas échéant)
- Famille produit, segment de marché, statut commercial (actif, arrêté, en test, etc.)
- Conditionnements disponibles, formats, unités de mesure
- Zones géographiques de distribution, langues disponibles
Caractéristiques & sécurité
- Composition, ingrédients, INCI, propriétés principales et secondaires
- Posologie, modes d’application, indications, effets attendus (si applicable)
- Allergènes, risques d’usage, substances interdites
- Données cliniques, tests d’efficacité ou de tolérance (si applicable)
- Schémas, fiches techniques, propriétés physico-chimiques, tests microbiologiques
- Notices techniques / d’utilisation (produits de soin, dispositifs médicaux, etc.)
Logistique & diffusion
- Conditionnements primaire & secondaire, infos d’emballage (pictos, braille, code emballeur)
- Numéros de lot & de série, dates d’expiration, traçabilité
- Contraintes de stockage, température, transport
- Lieu de fabrication, origine / provenance
- Logos, visuels produits (pack, ambiance, texture, usage), vidéos, documents marketing
- Mentions marketing validées, droits d’auteur, dates de validité
- Adaptation des contenus selon les canaux (site e-commerce, marketplaces, brochures, PLV)
- Vidéos d’usage / démonstration (grand public, professionnels de santé, etc.)
Statut & conformité
- Statut produit : médicament, dispositif médical, complément alimentaire, cosmétique, etc.
- Mentions obligatoires : AMM, certifications CE, allégations encadrées, statut bio, vegan, etc.
- Conformité aux référentiels : MDR, INCI, GDSN, DPP, RCP, etc.
Règlementaire & institutionnel
- Dossiers réglementaires : certificats d’innocuité, fiches de sécurité, déclaration centre antipoison
- Données institutionnelles : RCP, notices, organismes référents (ANSM, EMA, FDA, DGCCRF, etc.)
- Documentation réglementaire ou scientifique (incluant notices et fiches de sécurité pour archivage)
Preuves & certifications qualité
- Certificats qualité : ISO, CE, bio, dermatologique, etc.
- Résultats de tests : challenge test, stabilité, efficacité
- etc.
Fournisseurs & Partenaires
- Raison sociale, localisation, contacts
- Certifications fournisseurs
- Lien avec les matières premières ou produits finis
Approvisionnement, staocks & facturation
- Commandes,
- Stocks,
- Facturation
Réseau de distribution & exigences canal
- Réseau : points de vente, officines, entrepôts, marketplaces, canaux partenaires
- Données commerciales : préférences de communication, zones livrables, horaires
- Données légales canal : mentions obligatoires selon les canaux, facturation, conformité logistique
