The time from publishing the requirements to approving an eCTD to finally becoming the eCTD mandatory, provides a good opportunity for organizations from the Pharma industry to develop their expertise and establish their eCTD partnerships. The eCTD provides greater consistency and harmonisation to the regulatory landscape. Although this is a positive change for the regulatory community, a period of adjustment and learning will also be needed for all. It also requires organizations to prepare the relevant software, test it, define processes involved and be prepared with expert resources.
There is a lot of work for both businesses and regulators to do to be ready for China eCTD. Gaining expertise with eCTD will be crucial or partnering with an experienced partner who can share best practices and skills to staffing. Through staying on top of the policy updates, compliance teams will make their jobs easier when NMPA regulators finalize the paperwork.
Another important step will be to determine the readiness of the organization for eCTD from the perspective of people, processes, and resources to identify gaps. The earlier the differences are addressed, the easier it will be to ensure the company is able to comply with the new regulations and stay ahead of competition.
The global regulatory environment is continuing to evolve in terms of compliance, oversight, and enforcement requirements. The experts at Celegence have access to the most detailed, accurate and reliable business and regulatory information available, including global regulations, agency dynamics and new markets, regulatory changes, and updates.
Celegence can provide its customers around the world a head-start in meeting Chinese new standards for eCTD submissions. As a top provider of publishing and submission services, Celegence can also contribute its own publishing tool or leverage sponsors’ tools and technologies to manage submissions to China.