China Drug Registration Classification System | ChemLinked

13 May.,2024

 

China Drug Registration Classification System | ChemLinked

Understanding China Pharmaceutical Regulations Webinar Series in H2 2021

Link to Hengkang

China's pharmaceutical industry is experiencing rapid development these years. The growth can't be achieved without the incentive policies introduced by the Chinese government. The government has been working to improve the pharmaceutical regulatory environment and ensure that medicines are accessible to Chinese patients.

Given the growing concern of the Chinese people for health and the huge potential of the Chinese market, more and more international pharmaceutical companies are trying to enter the market or claim a bigger share.

To help enterprises and individuals understand the current drug regulations and the industry trend in China, our ChemLinked BaiPharm Team launched a webinar series on China drug regulations.

In May and June this year, we organized three webinars "Chinese Drug Administration & Regulation System", "Chinese Drug Legislative Framework", and "DMF Filing for APIs, Pharmaceutical Excipients and Packaging Materials in China".

In the second half of 2021, we will hold webinars focusing on drug registration. We'll also introduce China's Marketing Authorization Holders (MAH) rules and drug licensing in/out deals. Please stay tuned to our updates.

Webinar topics could be revised or added based on the needs of our ChemLinked BaiPharm members. If you have any questions or advice, welcome to send an email to contact@chemlinked.com.

Session 4: China Drug Registration Classification System 

Before registering a drug in China, pharmaceutical companies need to know which classification the drug product belongs to. After that, the applicant will be able to prepare documents compliant with specific requirements and submit them according to corresponding procedures.

China initiated a reformed system for drug registration classification with the Administrative Measures for Drug Registration implemented since July, 2020. In the same year, the country's drug regulator National Medical Products Administration (NMPA) issued Chemical Drug Registration Classification and Its Application Dossier Requirements and Biological Product Registration Classification and Its Application Dossier Requirements. The two regulations elaborated on the details of the reformed system.

This session will decode China's current drug registration classification system and analyze how the system impacts drug application.

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How To Design Your Own Custom Supplement Formula - Hengkang ...

How To Design Your Own Custom Supplement Formula

So you want to create your very own custom formula, that’s awesome! The supplement industry is highly competitive so creating a customized formula is a great way to set yourself apart from your competition.

Plus, having a unique product will help you retain customers because they won’t be able to find your product anywhere else.

But before you jump into how to create your custom formula first let’s find out if a custom formula is really the ideal solution for your business.

Private Label or Custom Formula?

A private label supplement is a formula that’s mass produced and sold to many companies so that they can sell that product to their customers under their label. A custom formula, on the other hand, is completely unique to your company.

There are many pros and cons of each but here are a few questions to help you figure out which path you should take.

Should I Private Label?

Are you just starting out? If you’re just starting out in the world of supplements, private label products are a great way to get your feet wet with less risk.

Are you unsure of the specifics of your supplement? If you don’t have a lot of specifics in mind (color, flavor, dosage, etc.) private label products work great because all that work is done for you.

Not sure of ingredients? If you’re not sure which ingredients you want to include you should really be thinking private label. Those formulas have been designed with proven, popular ingredients.

Do you want a product that is already hot on the market? If you’re looking to capitalize on a trending supplement that customers are already searching for, you should consider private label.

Are you looking to minimize your financial investment? If you’re looking for a cheap option then private label is your answer. The minimum order quantities on private label supplements are much lower than custom supplements.

To learn more about private labeling, contact us today.

Should I Create a Custom Formula?

Do you know which ingredients you want to include in your formula?

Do you know how much of each ingredient you want to include?

Do you know how many servings per container you want?

Do you know how many units you want?

Do you know what type of supplement you want to create?

Do you know the what type of packaging you want to use?

Do you have the funds to at least purchase the minimum order quantity?

If you answered yes to all of these questions, then it’s time for you to think seriously about creating your own custom formula. Here’s how to get started

7 Questions to Ask When Creating Your Custom Supplement Formula

Creating your own custom supplement formula means doing your research and answering seven simple questions along the way. Some of these questions are simple and you might know the answer immediately but others will require you to do a deep dive. When you’re designing a high-quality supplement cutting corner is not an option!

Here are the 7 questions you need to answer to create your custom formula.

1. Type of Supplement

It might seem obvious but the first thing you need to know before starting the process of creating your custom formula is what type of supplement do you want to create. Are you interested in making a weight loss supplement, sports supplement like protein or BCAAs, a health supplement?

Knowing this first will help you answer all the other questions on this list.

2. List of ingredients

When creating your own custom formula it’s really up to you to decide which ingredients you want to use in order to make your product stand out in the market.

Obviously this is going to take some research. Find out which ingredients are trending and what’s up-and-coming. You also want to make sure that whatever ingredients you choose have plenty of research to back up their effectiveness.

The supplement industry has seen plenty of “hot new” ingredients come and go because the results customers saw did not live up to the hype. Look for academic research articles that discuss benefits and results in detail. Examine.com is a great place to start.

3. Amount of Ingredients

The next thing you need to know is how much of each ingredient you want to include in a serving. This is where doing your research on ingredients will come in handy.

Make sure that you include the right amount of the ingredient in order to get the promised results. Find out what dosage was used in the studies because that’s a great place to start when creating a high quality, powerful supplement.

Keep in mind that more is not always better. There are some ingredients that can cause unwanted side effects if the dosage is too high. Also keep in mind that the more of each ingredient you include will increase the size of each serving. Some customers won’t like having to take more than two capsules or tablets to get the full serving.

4. Supplement Form

There are a few basic forms of supplements to choose from:

For more Hengkang Biological Medicine Co., Ltdinformation, please contact us. We will provide professional answers.

Capsule

Tablet

Powder

Gel caps

Tablets and capsules are two of the most inexpensive options to manufacture. They’re also very flexible as far as which ingredients you can use plus they’re easy to ship.

5. Servings per container

Knowing how many servings you want to include might not seem like a big deal but there are a few things to consider.

First you’ll want to look at your competition to see what they offer. This can give you a good idea of what works and what’s popular. Servings per container usually revolve around a month or 2 months supply, so 30 or 60 servings.

Keep in mind the more servings the more expensive it is for your customer. Depending on your supplement a 60 day serving might seem too pricey for customers who don’t want to drop that much cash all at once.

The serving size and amount of servings will also affect your packaging. A larger serving size will mean you’ll need a bigger bottle/tub/bag unless you cut back on servings per container. This will affect your shipping costs which is why it’s important to think about.

6. Units Needed

We’ve already discussed that minimum order quantities for custom formulas are much higher than that of private label supplements. But you don’t necessarily want to order just the minimum.

Find out the lead time on production and shipping. Lead time is an important factor in deciding how many units you need. If your new supplement is a total hit, you don’t want to stock out and lose sales while waiting for the next shipment.

7. Desired Type of Container/Packaging

Your packaging is a reflection of your branding. Deciding what type of packaging to use is not only functional but it’s also a marketing tool. You want your supplement to look good whether you’re selling it on Amazon or in a retail store.

In these highly competitive spaces you need to catch the eye of your customer so it’s important to know what type of packaging your target demographic is drawn to.

Finding the Right Supplement Manufacturer

Now that you’ve figured out all the details, it’s time to find the right manufacturer to bring your formula to life. You want someone that has the experience and capacity to help you grow your business.

How To Create A Custom Vitamin Supplement Formula

1. The first way we can create your specific formula is to sit down with you one on one. Asking you questions on what ingredients you want in your supplement, and helping you discover and figure out what is the best way to help create a product that will accomplish the things you are looking for. This process can be a little more time-consuming.

2. The second way we can formulate your custom supplement. Is by you bringing us a supplement facts panel of a product that is similar to what you want to make. We can then go through the facts panel to help you edit it by removing or adding ingredients and amounts. To create the perfect supplement for your company. This is typically the best and fastest way to create a new supplement for a variety of reasons. Creating a custom supplement this way gives you a few advantages, such as marketability and demand forecasting. 

How to Make Your Own Supplement Brand: Preparing the Formula

The vast majority of American adults take supplements, and the supplement industry brings in more than $30 billion dollars per year. Although supplements’ efficacy is still debated among health care professionals, it’s not a debate among consumers.

Most people feel they can benefit from high-quality supplements. If you’re curious in venturing to create your own brand, the manufacturing process can seem complicated. Keep reading this guide to find out how you can utilize experts in the dietary supplement industry to help formulate and make your own supplement to sell.

Creating Your Supplement Brand

As long as you follow some guidelines, use high quality ingredients, and research the rules and regulations, your supplement brand should be ready to enter the market.

Most likely you will want to consider utilizing a contract manufacturer to produce your custom formula, or go the route of pre-manufactured private label product that is ready to place your brand label on. Either way offsets the risk and investment of establishing your own manufacturing plant, teams of researchers, developers, biochemists, and the in-depth knowledge of the FDA regulations and testing required for supplements.

Private Label Supplements

These are products that are created for mass production and distribution. This is where a manufacturer creates the supplement and the retailer sells it under their name. This is a great option if you’re just starting out in the supplement industry and you do not have the capacity to create your own supplement in – house.

A private label will take care of a lot of details and headaches you want to avoid.

You might be sure of the details, like dosages, colors, and flavors, or you might not have a full understanding of ingredients and their interactions. It might be that you want to ride the popularity of another product that’s trending, or you might need to minimize your investment.

Private label is the cheapest option because the minimum order quantities are very low.

Custom Label

This is your own brew, totally unique to your company and brand. No sharing. And if you’re feeling ambitious, it’s the way to go. First, check to see if you have all your bases covered.

Do you know the details for your custom blend supplement? Do you have a full list of ingredients, how much of each ingredient? Do you know how many servings you want each container to have, and do you know how many units you want? What kind of packaging do you want to use, and do you have all the funds necessary to purchase a minimum order quantity or more?

These are all questions you can ask a knowledgeable contract manufacturer. It is important to do a lot of research in order to pass FDA regulations. Let’s break down each of these considerations, so you know what to expect.

What Type of Supplement?

Ideally, you know what you want your supplement to help people with, or what area of their lifestyle you want to help them improve. Is this for weight loss? Is it for sports performance or mental sharpness? Is this for a specific issue, like muscle soreness or skin elasticity?

Knowing your target demographic and what they’re wanting to achieve with a supplement is vital.

List of ingredients: Research

First, find out what ingredients accomplish what problem you are trying to solve. Make sure that these ingredients are available, safe, and effective. Consulting with a manufacturer can help you make these decisions. Many supplements get hyped, only to underperform, so it is important to not shy on your research.

Start by looking at any research or clinicals that have been conducted using the ingredients you are considering. You want to be able to backup your ingredient choices with factual research. Truly high-quality supplements, like potent nutraceuticals, can do a lot of positive things for people.

Amounts?

Refer back to your research papers that discuss at what dose a study participant noticed an effect. When thinking of the dosage amounts, you need to ensure that the dosage will complete the goal you are trying to accomplish. While each individual can respond to different doses of things, having a ballpark range will really help your final product perform well on the market.

Pills, Powders, Gels?

You need to decide on your supplement delivery system. Take a look again at your target demographics, and keep in mind some of them have specific dietary or allergy requirements. Bear in mind that sometimes a supplement’s efficacy depends on its ability to survive its pass through the stomach.

Servings Per Container: Be Precise

Take a look at your potential competitors and see how many servings per container they offer their customers. If people are buying a certain amount for a certain price, that’s a good indicator for you. Most containers stick to monthly amounts. 30, 60, or 90 is a common amount.

The more servings, though, the more expensive your product will be for the buyer. You might want to offer a couple of different amount options, like a 30 day and 60 day supply.

How Many Units?

Custom formula minimums are higher than what a private label would require. But if you’ve got the funds, you might not want to order a minimum. What’s the lead time for production and shipping? Think positively here- if your supplement is in high demand right away, you don’t want it to run out and have customers waiting for more supply.

Get Creative With Branding

Your packaging is a reflection of your brand, your ideas, your goals for your customers. You’ll want it to be both physically appealing and functional. Catching the eye of a customer in a saturated supplement industry will really help you.

You’ll need to do more research to find out what’s attractive to your target demographic. Men? Women? Get familiar with what they buy.

Ready? Find A Manufacturer

Making your own supplement brand can take work and dedication. It requires heavy research, planning, and insight.

Intrigued with how possible it would be to make your own supplement? You might be wondering what supplement manufacturer to research in this process, and we’ve got that covered.

Assume full responsibility to satisfy all needs of our clients; achieve continual advancements by endorsing the expansion of our purchasers; turn into the final permanent cooperative partner of clientele and maximize the interests of clients for Softgels OEM ODM,cosmetics Supplements OEM ODM,custom herbal extract powder supplement,Liquid supplement OEM ODM,Turnkey Supplement OEM Manufacturing,Tablet Supplement OEM ODM,custom collagen gummy,private label gummy supplement

The company is the world’s best gummies oem odm supplier. We are your one-stop shop for all needs. Our staff are highly-specialized and will help you find the product you need.