Best Practices For Conducting Multinational Clinical Trials | Page 12

The protocol should reflect any dosing differences, and specific

Figure 6.

Possible Paths for an NDA in Singapore19

pharmacokinetics (PK) studies may be required. The requirements
for PK studies may differ from a full clinical trial, and it is best to
consult the head authority of the country before writing the protocol.

Marketing applications »

A full dossier

NDA

As with the initial trial application, considerable heterogeneity exists
between countries for the marketing application process. Taking
advantage of local expertise for marketing planning during protocol

An abridged dossier

development can reduce later setbacks resulting from inadequate
data or inappropriate timing.
A verification dossier

In China, an NDA is filed for a new drug, while an IDL is filed for an
existing drug (Table 4). If filing an NDA, the drug must not have been
approved in any other country at the time of application,8 and safety
and efficacy data from China are required. Only drug companies or
CROs registered in the People’s Republic of China are allowed to
apply. Upon completion of the clinical trial, the product must undergo
a quality test while applying for the NDA with enough samples for
three complete tests, including samples of the investigational drug,
drug substance for biological products, and reference standards.8
There are specific quality requirements that must be followed,
and the process can take at least three months.
In Hong Kong, a certified copy of the GMP certificate of the manufacturer
is required. For products containing a new chemical or biological entity,
official evidence of registration approval of the product in two or more
of the following countries must be provided: Australia, Austria, Belgium,
Bulgaria, Canada, Cyprus, Czech Republic, Denmark, Estonia, Finland,

France, Germany, Greece, Holland, Hungary, Ireland, Italy, Japan,
Latvia, Lithuania, Luxembourg, Malta, Poland, Portugal, Romania,
Slovak Republic, Slovenia, Spain, Sweden, Switzerland, UK, or USA.17
At least three months’ stability test data are required.
The application for an innovator product is required for a new drug
product or a biologic in Malaysia. The application for a generic product
is completed for a product that is essentially similar to a currently
registered product in Malaysia.18 The applicant must be registered locally,
and the manufacturer must follow GMP guidelines from their local
authority. Separate applications are required for different strengths/
dosages. To complete the application process, samples must be submitted
to the Centre for Quality Control within 14 days of application payment.

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