Description of content:
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Preparations
that can be taken without water (orally disintegrating tablets) are taken
from the category "special preparations" and moved to "general
preparations".
·
Establish
standards for the evaluation of safety and efficacy of preparations
administered through the inhalation of active drug substances, etc., so that
they are internationally harmonized.
·
Improve the
management of approval for active drug substances with different hydrates
that function equally in the human body.
·
Exclude ester
derivatives of already approved drug substances from the "new molecular
entity" category if it is identical to an approved drug when orally
taken and degraded in the digestive organs.
·
Streamline the
approval process for imported pharmaceuticals that have previously withdrawn
their domestic approval
·
Acknowledge
multiple specifications for an active substance in case of pharmacopoeia
specification.
·
Mandate GMP
evaluation in the approval process of pharmaceuticals intended for export.
·
Allow a
separate approval process for pharmaceuticals intended for export.
·
Rationalize the
domestic approval process for foreign new drugs by improving the scheme in
deciding whether to perform bridging studies.
·
Abolish
mandatory notification of drug substance's specification in the certificate,
which verifies the imported drugs' certification for manufacture and
marketing in the originating country.
·
Mandate the
submission of CTD for approval for generic drugs.
·
Mandate the
submission of data that proves the non-addition of harmful substances that
originated from the container.
·
Strengthen
safety management regulations for manufacturing processes of animal-derived
pharmaceuticals.
·
In addition to
bioequivalence study, secure a method to ensure credibility of
pharmacokinetics data(Audit-trail) of phase 1 clinical trial
·
Mandate
stability test report submission of generic drugs.
·
Improve the
display/presentation of posology/method of administration for paediatric
drugs.
·
Introduce a
method to provide professional approval information for experts (doctors,
pharmacists, etc).
·
Provide 4-year
exclusivity for pediatric drugs with added new indication or posology/method
of administration and orphan drugs whose efficacy and safety have been
verified by domestic clinical trials.
·
Mandate the
submission of verification data on microorganism specification in approval
processes of probiotics.
·
Strengthen
quality evaluation of subdivided pharmaceutical ingredients.
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