Drawing parallels between EU and Chinese safety regulations

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Needless to say, everyone within the industry is well aware of Asia’s potential in science and technology. But to understand more about the international perspective on expanding their business to Asia, we invite speakers from Asia and international market to provide a comprehensive overview of the global industry at BioPharma Asia Convention 2017, Singapore. One of the early confirmed international speakers is, Dr Mario Bertazzoli, Director and Head of Corporate Drug Safety at Helsinn SA, a Switzerland based pharma company with presence in EU, US and China. Dr Bertazzoli has over 25 years experience in pharma industry and his current responsibilities cover drug safety of several therapeutic products, including  oncology, pain & inflammatory.

Prior to the conference, we asked Dr Bertazzoli several questions to give you a preview on his knowledge sharing at  BioPharma Asia Convention 2017, Singapore.


Q: Oncology drugs tend to be toxic to both cancerous and normal cells. When working on an oncology drug, how do scientists make sure that the target has minimum toxicity on patients?

Bertazzoli: The concept for developing new oncology drugs recently has changed. In addition to traditional chemotherapy, immunotherapy has opened a new era in cancer treatment. While chemotherapy and radiotherapy target the tumor, immunotherapy awakens and enhances the patient’s immune system inducing it to attack tumor cells from within. This selectivity reduces toxicity for non-cancerous cells.


Q: Treating cancer patients is often challenging as complex syndromes may surface during the studies. In such cases, how do pharma companies decide if the drug is safe to be prescribed?

Bertazzoli: Through the analysis of safety data originating from pre-clinical studies, clinical trials and observational studies the company identify which patients are at increased risk of experiencing an adverse reaction. In addition, post-marketing spontaneous reporting better define the benefit-risk profile of the approved drugs. All these activities permit companies and regulators to weight the risk of taking the drug towards the expected benefits. In any case, for the single patient, the decision lies within the treating oncologist.


Q: What are the main similarities and discrepancies between EU and Asia regulations when it comes to drug safety?

Bertazzoli: Pharmacovigilance (PV) regulations are the same in all the European Union (EU) countries, while Asia has no harmonization in its regulations. EU PV regulations have International Conference of Harmonization (ICH) requirements as a basis. Some Asian countries, instead, have not completely implemented ICH regulations or they have different requirements. Recently Asian regulators tend to harmonize local PV regulations with ICH guidelines. However, many Asian regulations remain divergent from the EU regulations.


Q:What is your advice for European companies who want to venture into Asia market?


  • Understanding the various Asian cultures;
  • Acquiring adequate knowledge of a large and diverse geographic area of the globe with varying social and economic levels;
  • Preparing yourselves with knowledge of the various regulatory requirements for different countries, since they can be divergent from European ones;
  • Observing the language barrier, since Asian regulations are not always fully available in English


Q: What do you wish to see as the changes in Asia regulations in the next 5-10 years?

Speed up the harmonization process by fully implementing ICH/CIOMS guidelines.


Dr Mario Bertazzoli will be presenting his view on “Drawing parallels between EU and Chinese safety regulations” at BioPharma Asia Convention 2017, Singapore next 21-23 March.


About BioPharma Asia Convention 2017, Singapore

The 10th BioPharma Asia Convention will be held in Singapore on 21-23 March 2017. Attracting over 600 delegates and more than 1500 total attendees every year, this platform provides you with comprehensive overview of Asia’s biopharmaceutical industry development. Latest trends and developments of early R&D, clinical trials, manufacturing, supply chain, market access and medical affairs will be discussed extensively by key industry leaders and stakeholders in Asia.


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