pharma-congress-molecular-medicine-2018-posters

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O c t o b e r 1 9 - 2 0 , 2 0 1 8 | T o k y o , J a p a n

Pharma Congress 2018 & Molecular Medicine 2018

& Psychiatric Disorders 2018

Asian Journal of Biomedical and Pharmaceutical Sciences

ISSN: 2249-622X

Volume 8

International Conference on

PHARMACEUTICS AND NOVEL DRUG DELIVERY SYSTEMS

International Conference on

CELLULAR AND MOLECULAR MEDICINE

Annual Congress on

PSYCHIATRY AND PSYCHIATRIC DISORDERS

OF EXCELLENCE

IN INTERNATIONAL

MEETINGS

YEARS

Asian J Biomed Pharmaceut Sci 2018, Volume 8 | DOI: 10.4066/2249-622X-C3-009

CMC STRATEGIES TO EFFECTIVELY MANAGE CMC DATA CHALLENGES

AND ENSURE REGULATORY COMPLIANCE IN JAPAN

Seema Singh

Impute Inc., Japan

he amount of Chemistry, manufacturing, and controls (CMC) information needed varies according to formulation type, drug cate-

gory and jurisdictions. And Japanese regulatory landscape is often perceived as having complicated processes, stringent drug ap-

proval standards, language and culture barrier, which are considered by many to be the most challenging in the world. It’s very important

to understand Japan specific regulatory requirements and preemptively identify CMC data challenges to enable accelerated drug de-

velopment and approval in Japan. The propose is to identify the priority measures and controls that companies should have in place to

build quality into procedures for compiling flawless regulatory submissions and to reduce review time by minimizing regulatory queries,

appropriately deal with CMC data challenges. Scientific, robust and adaptive CMC development strategy is essential when dealing with

PMDA-interactions, submission conformance or compliance and overall probability of success of the Japan-NDA. Key considerations

for formulating and implementing a successful regulatory strategy are: Understanding of marketing authorization application process,

key stages, PMDA review and expectations; CMC requirements in Japan focusing on rationalization for setting scientifically sound

specifications, stability program, correct interpretation of stability data and shelf life claim as specification and stability are of immense

importance in the development of safe and efficacious formulations; CMC review and GMP compliance and; how to utilize prior explicit

and tacit knowledge on CMC requirements from successful approvals or PMDA quality consultations meetings, tactical planning, alter-

native approaches to justify data lacking in CMC package and to ensure the requirements are met to PMDA approval process.