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License Approval: Pharmaceuticals
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China Concept Research
License Approval: Pharmaceuticals

Our Challenge: To acheive timely renewal of our client's license to sell its imported serum products in China
  • Client: "BioPharmaCo", a medium-sized European bio-pharmaceutical company
  • Our Mission: To develop and implement a results-oriented government communications strategy that would result in our client receiving approval to import its products in China.  When we were hired, the client's application had already been rejected, and they needed us to understand why and fix the situation.
  • Obstacles
    • Regulatory complications
      • Recent transfer for regulatory responsibilities to new government bodies greatly slowed the processing of application renewals.  During the regulatory reshuffling, regulators misplaced crucial documentation.  Miscommunication among regulators - such as lost documentation - was among the reasons BioPharmaCo's application was rejected.
      • Due to fears of HIV transmission, regulators were uncertain if the serum products in question were suitable for import.
    • Threats to client
      • No guarantee how long registration renewal would take
      • Possibility that renewal would be rejected outright and a lengthy reapplication process - including new clinical trials - would be required
      • Possibility that even after reapplication, the import would be forbidden
Our Integrated Approach: Developed and implemented a government communications strategy based on in-depth reserach
  • Industry Intelligence: Conducted a policy & situation analysis to understand:
    • Reforms of all related regulatory department
    • Drug registration regulations
    • Policies on imported pharmaceuticals
    • Related laws and regulations
  • Corporate Diplomacy: Targets identification - the key government and industry stakeholders
    • Old industry regulator (Ministry of Health)
    • Newly-established regulatory body (State Drug Administration)
    • Influential industry experts and opinion-leaders
  • Corporate Diplomacy: Message Development
    • Product meets the stringent stafety requirements in the client's country
    • Client's products have strong safety records
Implementation: The government communications strategy relied on facts gathered in the research stage and on relationships built up over time to effectively communicate with and influence decision-makers
  • Facilitated opinon-leaders & industry experts (i.e. those outside the government) to:
    • Visit the client
    • Know safety facts about the client's products
    • Understand the safety controls in the client's country
    • Report to regulators in China
    • Participate in seminars & write articles
  • Coordinated government relation-based activities
    • Meetings with top industry regulator
    • Published an industry guidebook in cooperation with top regulator
    • Publicized industry news on-line in co-operation with regulatory body
    • Facilitated top industry regulator's visit to the client
Results: A shortcut to approval
  • With China Concept: BioPharmaCo succeeded in renewing the license for its serum products within 2.5 years, saving much effort and time.
  • Without China Concept: On its own, BioPharmaCo would have risked being refused to register, or at the least would have invested much more time and effort, including conducting clinical trials in China, for its application.  This process could have taken up to 10 years