Listen to What Is...?
What is Drug Administration Law (DAL)?
The National Medical Products Administration (NMPA) is the primary Regulatory Authority in China. It is the supporting agency of the State Administration for Market Regulation (SAMR). SAMR is the super ministry, and NMPA is its subordinate bureau. Further, the NMPA is also divided into various departments such as the Centre for Drug Evaluation (CDE), Centre for Drug Re-Evaluation (CDR), Centre for Medical Device Evaluation (CMDE), etc.
Earlier, China Food and Drug Administration (CFDA) was the only responsible authority that regulated pharmaceuticals and medical devices, but later in 2018, CFDA was reshaped into smaller segments and called SAMR.
NMPA oversees the pre-market approvals, distribution, and manufacturing, and post-marketing activities. NMPA is divided into different departments, and it also has affiliated centres that cover different products of the Regulatory market.
As conventionally observed in the US, there are different laws that regulate different products, such as drugs, devices, foods, and cosmetics. On the contrary, there is entirely a separate law or an administrative regulation overlooking these areas. The directive regulating drugs along with biologics is DAL. The State Council has approved a general set of implementing rules for the DAL, referred to as Drug Administration Law Implementing Regulations (DALIR)
A new Drug Administration Law (DAL) came into force on December 01, 2019. This revision is the most significant of all the other amendments. Other revisions were made in 2001, 2013, and 2015, but all these were partial revisions.
Major changes included in the new version of DAL are:
- 60-workday Deadline for Approval by NMPA: The new system announced that if the applicant does not receive any communication regarding the approval of the clinical trial application by NMPA within 60 working days, then the trial will be considered ‘approved’ by default.
- Legalization of Online Prescription Drug Sales: Prescription drugs can now be sold online by the marketing authorization holder (MAH), drug distributors, and third-party e-Commerce portals. However, vaccines and blood products are not included in this list.
- Application of the MAH System: In accordance with the prior system, only the regional drug manufacturers could receive the approval to market their products. Later after the implementation of the new system, the companies were able to outsource their manufacturing to contract manufacturing organizations (CMO). However, there was an exception for high-risk products like vaccines.
- Increased Penalties: Violation of DAL will invite administrative penalties. These penalties have been increased and also impose personal liability on individuals responsible for corporate violations.
China’s pharmaceutical market is highly governed by tedious regulations and dynamic laws. We, at Freyr, with a team of highly qualified professionals, can help you with a quick, effective, and smooth drug registration procedure in China.
To know more, consult our Regulatory experts at Freyr!