Regulatory, Development and Commercial Expertise for the China Market.

CHINA ADVISORY SERVICES

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Navigating China’s dynamic development and commercial environment takes an experienced team you can trust.

YOUR JOURNEY.OUR MISSION.®

China already imports well over $20 billion of pharmaceuticals each year. By 2020, China will be the #2 pharmaceutical market in the world and healthcare spending in China is expected to continue increasing over the following decade. Systematic and fundamental changes are already happening in China in response to this rapid growth.*

Regulatory reform such as accelerated approvals for innovative drugs, a streamlined clinical trial approval process (CTA), increased reviewers, an expansion of clinical trial resources and the acceptance of foreign data by the China Food & Drug Administration (CFDA) / National Medical Products Administration (NMPA) present opportunities in China like never before.

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* International Federation of Pharmaceutical Manufacturers and Associations, Facts & Figures 2017

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China’s regulator, the National Medicinal Products Administration (NMPA), formerly CFDA, have gone through considerable reform very recently. The goal was to establish a US-FDA like consultation meeting mechanism. Expedited new drug processes have been established. The NMPA plans to significantly increase the number of reviewers from about 90 to 300+ and plans to expand the team of 600 reviewers in two years.

China is striving to quickly establish to a systematic, payment-based health system, which has been driven primarily by public health concerns and the Chinese government’s goal to cover all citizens. The Chinese government strictly controls the price of new medicines, and the price-setting process in China takes place

separately from reimbursement. To add to the challenge of gaining coverage, drug formularies in China are typically updated only once every five years.

To tap into the China opportunity and obtain maximum results, you need guidance from professionals who have all of the latest knowledge on NMPA regulations – including ex-CFDA and NMPA regulators on staff who shaped and implemented regulations in China. You also need expertise that can help simplify the complex market access and commercial environment, reduce the risk of unnecessary delays to market and help grow sales rapidly.

WHILE CHINESE REFORMS ARE MAKING THE MARKET IN CHINA MORE ACCESSIBLE TO GLOBAL PHARMACEUTICAL COMPANIES, THERE ARE HURDLES THAT NEED TO BE OVERCOME TO NAVIGATE THIS DYNAMIC REGULATORY, MARKET ACCESS AND COMMERCIAL LANDSCAPE.

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INTRODUCING PAREXEL’S NEW CHINA ADVISORY SERVICES

OUR CHINA ADVISORY SERVICES INCLUDE:

Regulatory Strategy

• Global product development strategy, Clinical, Non-clinical, CMC and Regulatory gap analysis, Due-diligence, Product and Indication prioritization, Regulatory pathway optimization and Acceleration strategy, Global labeling (CCDS updates), Marketing authorization applications (US, EU, China, Japan, Canada and Emerging Markets-ROW), Submission planning (eCTD), Patient-focused development

• Health Authority Meetings: preparation support, briefing documents, rehearsals, meeting attendance and health authority liaison

• Quality systems inspection strategy and inspection readiness

• Strategic Compliance and risk management: facility remediation and audits

• Submission Support: storyboarding/key messaging, core submission preparation and authoring, original application publishing with lifecycle maintenance, lifecycle publishing, global dossier management, RTQs, CTA core dossier development

• Stakeholder Management: Drug safety, tech opps, medical, commercial, CMOs

• Mergers and Acquisitions: Planning, submission authoring, dossier collection and stakeholder management local (affiliate) level

• Regulatory Strategy: Market-specific requirements/regulatory intelligence, local labeling/artwork, MAAs

• Submission Support: Variations, renewals, annual reports, RTQs, publishing, RIM support, archiving, CTA submissions

• Stakeholder Management: Health agencies, GRA, Local safety, local QA

• Regulatory writing/authoring to local affiliate level

We have created a new advisory service to help companies outside of China who are looking to take their products to the China market. Our new China Advisory Service will provide regulatory, development and commercial expertise that will help companies understand how they can evaluate their opportunity in China, become a Marketing Authorization Holder (MAH) in China, ensure compliance with NMPA, attain favorable formulary status and pricing, and grow sales rapidly.

Working together, we can help you plan earlier to extract greater value from your clinical trial data, and convert end-to-end clinical development, and commercial expertise into actions that speed the delivery of your therapy to the patients who need them.

Our China Advisory team includes 4 ex-FDA, 3 ex-NMPA/CFDA regulators, 8 dedicated China regulatory consultants, clinical development experts and Market Access Experts.

PAREXEL HAS A DEEP BENCH OF FORMER CFDA/NMPA REGULATORS ON STAFF WHO SHAPED AND IMPLEMENTED REGULATIONS IN CHINA. AND NOW—THEIR EXPERTISE IS AVAILABLE TO YOU.

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Commercial Strategy

• Map the patient journey

• Document physician referral patterns

• Evaluation and prioritization of specific patient subsets

• Recommendations for additional endpoints for clinical trial protocols to address market access requirements

• Analysis recommending optimal pricing to maximize gross profits

• Economic justification for optimal pricing and value propositions

• Prioritization of target customers

• Assessment of alternative distribution channels and partners

• Evaluation of “go-to-market” plans (direct salesforce vs. partnering options)

• Product lifecycle management, including potential reformulations and novel delivery devices

Because knowledge can quickly become outdated, it’s more important than ever to work with professionals who are continuously updating their knowledge in complex product development and the marketplace. That’s PAREXEL.

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When you’re ready for a faster, smoother development journey, PAREXEL is ready to help you achieve it. For more information please visit: www.PAREXEL.com/China-Ad-visory-Services

WHEREVER YOUR JOURNEY TAKES YOU, WE’RE CLOSE BY.

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