Pharmaceuticals Registration in Mexico

‘After Brazil, Mexico has the second largest pharmaceutical market in Latin America. With more than 11 billion units of products sold in 2019, the country’s wholesale pharmaceutical industry reached a revenue of more than 174 billion Mexican pesos, or approximately 8.4 billion U.S. dollars.’ Statista

 

Pharmaceutical products are regulated by COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios) in Mexico.

 

Artixio’s regional presence in Mexico and experience with pharmaceutical products compliance in the country has helped our clients access the market to register and introduce their pharmaceutical products in Mexico. We can support through entire product lifecycle using regulatory advisory and operational services for new molecules, generic drugs, biologics and biosimilars.

 Regulatory Strategy & Intelligence

Artixio’s regional regulatory experts provide insights into Mexico regulations for pharmaceutical and biologic products right from development to authorization. Depending on the stage you are in of your journey, our team can provide you evidence based strategic insights to make suitable decision for successful product registration in Mexico. Our services include,

  • Insights on Mexico’s Regulations for New Molecules, Generics, Biologics, Biosimilars and Combination products

  • Consultation on Regulatory Pathway for your product and therapeutic indication

  • GMP and audit requirements based on your existing approvals in other countries

  • Insights on pricing, market opportunity, distribution channels and cost of landing the product

  • COFEPRIS consultation strategy  

Regulatory Affairs

Our experience with COFEPRIS and regional experts support our clients with end to end registration of pharmaceutical and biologic products in Mexico. Our services include,

  • Dossier gap analysis based on existing approvals in reference markets (USA, EU, Australia etc.)

  • Dossier preparation for COFEPRIS submission

  • Consultation meeting with COFEPRIS

  • Response to queries

  • Obtaining license post approval  

Regulatory Operations

  • : Our regulatory operations services support pre and post registration of pharmaceutical products.

    • Publishing and submission in required format

    • Notarization where applicable

    • Translation in Spanish

    • Regulatory Information Management

    • Post Approval Maintenance such as license renewals, annual reports

Labeling & Artwork

Our end to to end labeling and artwork services support compliance driven labeling content authoring, graphic design and printing for pharmaceutical products. With teams experienced in managing clinical and commercial labeling for diverse products, Artixio provides high quality services to supporting our clients' labeling and artwork requirements.  

  • Target Product Profile 

  • Core Data Sheet Authoring and Management 

  • Core Safety Information Authoring 

  • Literature Search and Review 

  • Medical Writing 

  • Labeling Operations Management 

  • International Labeling 

  • SmPC, PIL Support 

  • Artwork Proof Reading (SmPC, PIL, Blister Packs, Cartons etc.)

  • Graphic Design 

  • Artwork Change Management 

  • Artwork Process Coordination 

  • Labeling and Artwork Project Management

Artixio's Labeling and Artwork Professionals are based in USA, Europe and India.

Market Access

Enabling patients’ access to therapies requires authorization from health authorities and payers’ acceptance of pricing based on therapy’s benefits and advantages over existing options. The pricing is driven by insights from key opinion leaders, prescribers’ understanding of the therapy, payers’ policies and regulatory framework on certain disease areas in the country.

 

The key benefits and advantages over existing treatments are part of drug development planning and therefore, it can be stated that Market Access is a key consideration right from the early stage of drug development.

 

Artixio’s team brings wealth of experience across complex therapeutic areas and global markets to help you address key questions for your market access strategy –

Pricing:

  • Targeting expected indication and therapy

  • Existing therapeutic modalities and line of therapy

  • KOL opinion on new therapy’s advantages and benefits over current options;

  • Price comparator with existing therapies under applicable treatment setups to assess ‘effective cost of treatment’ through the lifecycle of treatment

  • Risks based on side effects

  • Scientific data supporting product’s advantages

Reimbursement:

  • Reimbursement policies in the country

  • Timeline and process for reimbursement approvals

  • Identification of primary markets for product launch based in reimbursement scenario

Market Intelligence

Artixio enables data driven executive decisions across C-Level, marketing, R&D, clinical, regulatory and commercial department right from product development, product launch and post marketing support. Our team has decades of experience and insights to global markets in planning and commercializing pharmaceutical, med-tech, cosmetic and nutrition products.

 

Our comprehensive market intelligence approach covers all key areas of life-sciences products to enable critical commercial decisions for,

  • Develop key product differentiators and product development plan

  • Competitor analysis (business, Intellectual Property, clinical, product claims/benefits etc) and developing counter competitive strategies

  • Market landscape analysis to

    • quantify market opportunity and market size

    • identify key sales and distribution channels (pharmacy and retail sales, hospital sales, salons/spas, online ecommerce and others)

    • Develop country specific product launch strategy – product portfolio selection, pricing, sales/distribution channels, marketing messages, marketing collateral requirements, regional Key Opinion Leaders, consortiums and events

  • Assess target market and key market positioning

  • Develop key marketing strategy and marketing messages

  • Pricing benchmarking for product positioning and value proposition

  • Disease Area Strategy based on therapeutic area landscape analysis, therapeutic modalities and cost of treatment

  • Clinical Intelligence to assess competitors’ product development and clinical strategy to develop a differentiated clinical development roadmap